Detection and escalation of security responses of surgical instruments to increasing severity threats

ABSTRACT

A surgical instrument for use with a surgical hub in a surgical procedure is disclosed. The surgical instrument includes a surgical end effector, a communication module configured to wirelessly pair the surgical instrument to the surgical hub, and a control circuit. The control circuit is configured to detect a first security violation, cause the surgical instrument to generate a first response to the first security violation, store a record of the first security violation, detect a second security violation, and cause the surgical instrument to generate a second response to the second security violation, wherein the second response is escalated from the first response.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims priority under 35 U.S.C. § 119(e) to U.S.Provisional Patent Application No. 62/729,177, titled AUTOMATED DATASCALING, ALIGNMENT, AND ORGANIZING BASED ON PREDEFINED PARAMETERS WITHINA SURGICAL NETWORK BEFORE TRANSMISSION, filed on Sep. 10, 2018, thedisclosure of which is herein incorporated by reference in its entirety.

The present application also claims priority under 35 U.S.C. § 119(e) toU.S. Provisional Patent Application No. 62/692,747, titled SMARTACTIVATION OF AN ENERGY DEVICE BY ANOTHER DEVICE, filed on Jun. 30,2018, to U.S. Provisional Patent Application No. 62/692,748, titledSMART ENERGY ARCHITECTURE, filed on Jun. 30, 2018, and to U.S.Provisional Patent Application No. 62/692,768, titled SMART ENERGYDEVICES, filed on Jun. 30, 2018, the disclosure of each of which isherein incorporated by reference in its entirety.

The present application also claims priority under 35 U.S.C. § 119(e) toU.S. Provisional Patent Application No. 62/659,900, titled METHOD OF HUBCOMMUNICATION, filed on Apr. 19, 2018, the disclosure of each of whichis herein incorporated by reference in its entirety.

The present application also claims priority under 35 U.S.C. § 119(e) toU.S. Provisional Patent Application No. 62/650,898 filed on Mar. 30,2018, titled CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAYELEMENTS, to U.S. Provisional Patent Application Ser. No. 62/650,887,titled SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES, filed Mar.30, 2018, to U.S. Provisional Patent Application Ser. No. 62/650,882,titled SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM, filedMar. 30, 2018, and to U.S. Provisional Patent Application Ser. No.62/650,877, titled SURGICAL SMOKE EVACUATION SENSING AND CONTROLS, filedMar. 30, 2018, the disclosure of each of which is herein incorporated byreference in its entirety.

The present application also claims priority under 35 U.S.C. § 119(e) toU.S. Provisional Patent Application Ser. No. 62/640,417, titledTEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR,filed Mar. 8, 2018, and to U.S. Provisional Patent Application Ser. No.62/640,415, titled ESTIMATING STATE OF ULTRASONIC END EFFECTOR ANDCONTROL SYSTEM THEREFOR, filed Mar. 8, 2018, the disclosure of each ofwhich is herein incorporated by reference in its entirety.

The present application also claims priority under 35 U.S.C. § 119(e) toU.S. Provisional Patent Application Ser. No. 62/611,341, titledINTERACTIVE SURGICAL PLATFORM, filed Dec. 28, 2017, to U.S. ProvisionalPatent Application Ser. No. 62/611,340, titled CLOUD-BASED MEDICALANALYTICS, filed Dec. 28, 2017, and to U.S. Provisional PatentApplication Ser. No. 62/611,339, titled ROBOT ASSISTED SURGICALPLATFORM, filed Dec. 28, 2017, the disclosure of each of which is hereinincorporated by reference in its entirety.

BACKGROUND

The present disclosure relates to various surgical systems. Surgicalprocedures are typically performed in surgical operating theaters orrooms in a healthcare facility such as, for example, a hospital. Asterile field is typically created around the patient. The sterile fieldmay include the scrubbed team members, who are properly attired, and allfurniture and fixtures in the area. Various surgical devices and systemsare utilized in performance of a surgical procedure.

Furthermore, in the Digital and Information Age, medical systems andfacilities are often slower to implement systems or procedures utilizingnewer and improved technologies due to patient safety and a generaldesire for maintaining traditional practices. However, often timesmedical systems and facilities may lack communication and sharedknowledge with other neighboring or similarly situated facilities as aresult. To improve patient practices, it would be desirable to find waysto help interconnect medical systems and facilities better.

SUMMARY

In various embodiments, a surgical instrument for use with a surgicalhub in a surgical procedure is disclosed that includes a surgical endeffector, a communication module configured to wirelessly pair thesurgical instrument to the surgical hub, and a control circuit. Thecontrol circuit is configured to detect a first security violation,cause the surgical instrument to generate a first response to the firstsecurity violation, store a record of the first security violation,detect a second security violation, and cause the surgical instrument togenerate a second response to the second security violation, wherein thesecond response is escalated from the first response.

In various embodiments, a surgical instrument for use with a surgicalhub in a surgical procedure is disclosed that includes a surgical endeffector, a communication module configured to wirelessly pair thesurgical instrument to the surgical hub, and a control circuit. Thecontrol circuit is configured to detect a first unauthorizedinteraction, cause the surgical instrument to generate a first responseto the first unauthorized interaction, store a record of the firstunauthorized interaction, detect a second unauthorized interaction, andcause the surgical instrument to generate a second response to thesecond unauthorized interaction, wherein the second response isescalated from the first response.

In various embodiments, a surgical instrument for use with a surgicalhub in a surgical procedure is disclosed, wherein the surgicalinstrument includes a surgical end effector, a communication moduleconfigured to wirelessly pair the surgical instrument to the surgicalhub, and a control circuit. The control circuit is configured to detecta first unauthorized activation of the surgical instrument, cause thesurgical instrument to generate a first response to the firstunauthorized activation of the surgical instrument, store a record ofthe first unauthorized activation of the surgical instrument, detect asecond unauthorized activation of the surgical instrument, and cause thesurgical instrument to generate a second response to the secondunauthorized activation of the surgical instrument, wherein the secondresponse is escalated from the first response.

DRAWINGS

The various aspects described herein, both as to organization andmethods of operation, together with further objects and advantagesthereof, may best be understood by reference to the followingdescription, taken in conjunction with the accompanying drawings asfollows.

FIG. 1 is a block diagram of a computer-implemented interactive surgicalsystem, in accordance with at least one aspect of the presentdisclosure.

FIG. 2 is a surgical system being used to perform a surgical procedurein an operating room, in accordance with at least one aspect of thepresent disclosure.

FIG. 3 is a surgical hub paired with a visualization system, a roboticsystem, and an intelligent instrument, in accordance with at least oneaspect of the present disclosure.

FIG. 4 is a partial perspective view of a surgical hub enclosure, and ofa combo generator module slidably receivable in a drawer of the surgicalhub enclosure, in accordance with at least one aspect of the presentdisclosure.

FIG. 5 is a perspective view of a combo generator module with bipolar,ultrasonic, and monopolar contacts and a smoke evacuation component, inaccordance with at least one aspect of the present disclosure.

FIG. 6 illustrates individual power bus attachments for a plurality oflateral docking ports of a lateral modular housing configured to receivea plurality of modules, in accordance with at least one aspect of thepresent disclosure.

FIG. 7 illustrates a vertical modular housing configured to receive aplurality of modules, in accordance with at least one aspect of thepresent disclosure.

FIG. 8 illustrates a surgical data network comprising a modularcommunication hub configured to connect modular devices located in oneor more operating theaters of a healthcare facility, or any room in ahealthcare facility specially equipped for surgical operations, to thecloud, in accordance with at least one aspect of the present disclosure.

FIG. 9 illustrates a computer-implemented interactive surgical system,in accordance with at least one aspect of the present disclosure.

FIG. 10 illustrates a surgical hub comprising a plurality of modulescoupled to the modular control tower, in accordance with at least oneaspect of the present disclosure.

FIG. 11 illustrates one aspect of a Universal Serial Bus (USB) networkhub device, in accordance with at least one aspect of the presentdisclosure.

FIG. 12 is a block diagram of a cloud computing system comprising aplurality of smart surgical instruments coupled to surgical hubs thatmay connect to the cloud component of the cloud computing system, inaccordance with at least one aspect of the present disclosure.

FIG. 13 is a functional module architecture of a cloud computing system,in accordance with at least one aspect of the present disclosure.

FIG. 14 illustrates a diagram of a situationally aware surgical system,in accordance with at least one aspect of the present disclosure.

FIG. 15 is a timeline depicting situational awareness of a surgical hub,in accordance with at least one aspect of the present disclosure.

FIG. 16 is a logic flow diagram of a process depicting a control programor a logic configuration for adjusting surgical hub responses, inaccordance with at least one aspect of the present disclosure.

FIG. 17 is a timeline of an illustrative surgical procedure and thecorresponding information inferred by a surgical hub during theprocedure, in accordance with at least one aspect of the presentdisclosure.

FIG. 18 is a logic flow diagram of a process depicting a control programor a logic configuration for selecting operational modes of a surgicalhub, in accordance with at least one aspect of the present disclosure.

FIG. 19 is a logic flow diagram of a process depicting a control programor a logic configuration for determining whether a surgical procedure isunderway, in accordance with at least one aspect of the presentdisclosure.

FIG. 20 is a logic flow diagram of a process depicting a control programor a logic configuration for determining whether surgery is in progress,in accordance with at least one aspect of the present disclosure.

FIG. 21 is a logic flow diagram of a process depicting a control programor a logic configuration for responding to sensed parameters, inaccordance with at least one aspect of the present disclosure.

FIG. 22 is a logic flow diagram of a process depicting a control programor a logic configuration for adjusting operational parameters of asurgical stapler in the event of a detected security fault, inaccordance with at least one aspect of the present disclosure.

FIG. 23 also depicts various examples of responding to sensed parametersbased on a determined situational parameter, in accordance with at leastone aspect of the present disclosure.

FIG. 24 is a logic flow diagram of a process depicting a control programor a logic configuration for assessing operational fitness of a modulardevice, in accordance with at least one aspect of the presentdisclosure.

FIG. 25 is a logic flow diagram of a process depicting a control programor a logic configuration for generating suitable responses tounauthorized interactions with a modular device, in accordance with atleast one aspect of the present disclosure.

FIG. 26 is schematic diagram illustrating multiple components of amodular device, in accordance with at least one aspect of the presentdisclosure.

FIG. 27 is a logic flow diagram of a process depicting a control programor a logic configuration for generating suitable responses tounauthorized interactions with a modular device, in accordance with atleast one aspect of the present disclosure.

DESCRIPTION

Applicant of the present application owns the following U.S. patentapplications, filed on Nov. 6, 2018, the disclosure of each of which isherein incorporated by reference in its entirety:

-   -   U.S. patent application Ser. No. ______, titled SURGICAL        NETWORK, INSTRUMENT, AND CLOUD RESPONSES BASED ON VALIDATION OF        RECEIVED DATASET AND AUTHENTICATION OF ITS SOURCE AND INTEGRITY,        Attorney Docket No. END9012USNP1/180511-1;    -   U.S. patent application Ser. No. ______, titled SURGICAL SYSTEM        FOR PRESENTING INFORMATION INTERPRETED FROM EXTERNAL DATA,        Attorney Docket No. END9012USNP2/180511-2;    -   U.S. patent application Ser. No. ______, titled MODIFICATION OF        SURGICAL SYSTEMS CONTROL PROGRAMS BASED ON MACHINE LEARNING,        Attorney Docket No. END9012USNP3/180511-3;    -   U.S. patent application Ser. No. ______, titled ADJUSTMENT OF        DEVICE CONTROL PROGRAMS BASED ON STRATIFIED CONTEXTUAL DATA IN        ADDITION TO THE DATA, Attorney Docket No. END9012USNP4/180511-4;    -   U.S. patent application Ser. No. ______, titled SURGICAL HUB AND        MODULAR DEVICE RESPONSE ADJUSTMENT BASED ON SITUATIONAL        AWARENESS, Attorney Docket No. END9012USNP5/180511-5;    -   U.S. patent application Ser. No. ______, titled INTERACTIVE        SURGICAL SYSTEM, Attorney Docket No. END9012USNP7/180511-7;    -   U.S. patent application Ser. No. ______, titled AUTOMATED DATA        SCALING, ALIGNMENT, AND ORGANIZING BASED ON PREDEFINED        PARAMETERS WITHIN SURGICAL NETWORKS, Attorney Docket No.        END9012USNP8/180511-8;    -   U.S. patent application Ser. No. ______, titled SENSING THE        PATIENT POSITION AND CONTACT UTILIZING THE MONO-POLAR RETURN PAD        ELECTRODE TO PROVIDE SITUATIONAL AWARENESS TO A SURGICAL        NETWORK, Attorney Docket No. END9013USNP1/180512-1;    -   U.S. patent application Ser. No. ______, titled POWERED SURGICAL        TOOL WITH PREDEFINED ADJUSTABLE CONTROL ALGORITHM FOR        CONTROLLING END EFFECTOR PARAMETER, Attorney Docket No.        END9014USNP1/180513-1;    -   U.S. patent application Ser. No. ______, titled ADJUSTMENTS        BASED ON AIRBORNE PARTICLE PROPERTIES, Attorney Docket No.        END9016USNP1/180515-1;    -   U.S. patent application Ser. No. ______, titled ADJUSTMENT OF A        SURGICAL DEVICE FUNCTION BASED ON SITUATIONAL AWARENESS,        Attorney Docket No. END9016USNP2/180515-2;    -   U.S. patent application Ser. No. ______, titled REAL-TIME        ANALYSIS OF COMPREHENSIVE COST OF ALL INSTRUMENTATION USED IN        SURGERY UTILIZING DATA FLUIDITY TO TRACK INSTRUMENTS THROUGH        STOCKING AND IN-HOUSE PROCESSES, Attorney Docket No.        END9018USNP1/180517-1;    -   U.S. patent application Ser. No. ______, titled USAGE AND        TECHNIQUE ANALYSIS OF SURGEON/STAFF PERFORMANCE AGAINST A        BASELINE TO OPTIMIZE DEVICE UTILIZATION AND PERFORMANCE FOR BOTH        CURRENT AND FUTURE PROCEDURES, Attorney Docket No.        END9018USNP2/180517-2;    -   U.S. patent application Ser. No. ______, titled IMAGE CAPTURING        OF THE AREAS OUTSIDE THE ABDOMEN TO IMPROVE PLACEMENT AND        CONTROL OF A SURGICAL DEVICE IN USE, Attorney Docket No.        END9018USNP3/180517-3;    -   U.S. patent application Ser. No. ______, titled COMMUNICATION OF        DATA WHERE A SURGICAL NETWORK IS USING CONTEXT OF THE DATA AND        REQUIREMENTS OF A RECEIVING SYSTEM/USER TO INFLUENCE INCLUSION        OR LINKAGE OF DATA AND METADATA TO ESTABLISH CONTINUITY,        Attorney Docket No. END9018USNP4/180517-4;    -   U.S. patent application Ser. No. ______, titled SURGICAL NETWORK        RECOMMENDATIONS FROM REAL TIME ANALYSIS OF PROCEDURE VARIABLES        AGAINST A BASELINE HIGHLIGHTING DIFFERENCES FROM THE OPTIMAL        SOLUTION, Attorney Docket No. END9018USNP5/180517-5;    -   U.S. patent application Ser. No. ______, titled CONTROL OF A        SURGICAL SYSTEM THROUGH A SURGICAL BARRIER, Attorney Docket No.        END9019USNP1/180518-1;    -   U.S. patent application Ser. No. ______, titled SURGICAL NETWORK        DETERMINATION OF PRIORITIZATION OF COMMUNICATION, INTERACTION,        OR PROCESSING BASED ON SYSTEM OR DEVICE NEEDS, Attorney Docket        No. END9032USNP1/180519-1;    -   U.S. patent application Ser. No. ______, titled WIRELESS PAIRING        OF A SURGICAL DEVICE WITH ANOTHER DEVICE WITHIN A STERILE        SURGICAL FIELD BASED ON THE USAGE AND SITUATIONAL AWARENESS OF        DEVICES, Attorney Docket No. END9032USNP2/180519-2;    -   U.S. patent application Ser. No. ______, titled ADJUSTMENT OF        STAPLE HEIGHT OF AT LEAST ONE ROW OF STAPLES BASED ON THE SENSED        TISSUE THICKNESS OR FORCE IN CLOSING, Attorney Docket No.        END9034USNP1/180521-1;    -   U.S. patent application Ser. No. ______, titled STAPLING DEVICE        WITH BOTH COMPULSORY AND DISCRETIONARY LOCKOUTS BASED ON SENSED        PARAMETERS, Attorney Docket No. END9034USNP2/180521-2;    -   U.S. patent application Ser. No. ______, titled POWERED STAPLING        DEVICE CONFIGURED TO ADJUST FORCE, ADVANCEMENT SPEED, AND        OVERALL STROKE OF CUTTING MEMBER BASED ON SENSED PARAMETER OF        FIRING OR CLAMPING, Attorney Docket No. END9034USNP3/180521-3;    -   U.S. patent application Ser. No. ______, titled VARIATION OF        RADIO FREQUENCY AND ULTRASONIC POWER LEVEL IN COOPERATION WITH        VARYING CLAMP ARM PRESSURE TO ACHIEVE PREDEFINED HEAT FLUX OR        POWER APPLIED TO TISSUE, Attorney Docket No.        END9035USNP1/180522-1; and    -   U.S. patent application Ser. No. ______, titled ULTRASONIC        ENERGY DEVICE WHICH VARIES PRESSURE APPLIED BY CLAMP ARM TO        PROVIDE THRESHOLD CONTROL PRESSURE AT A CUT PROGRESSION        LOCATION, Attorney Docket No. END9035USNP2/180522-2.

Applicant of the present application owns the following U.S. patentapplications, filed on Sep. 10, 2018, the disclosure of each of which isherein incorporated by reference in its entirety:

-   -   U.S. Provisional Patent Application No. 62/729,183, titled A        CONTROL FOR A SURGICAL NETWORK OR SURGICAL NETWORK CONNECTED        DEVICE THAT ADJUSTS ITS FUNCTION BASED ON A SENSED SITUATION OR        USAGE;    -   U.S. Provisional Patent Application No. 62/729,177, titled        AUTOMATED DATA SCALING, ALIGNMENT, AND ORGANIZING BASED ON        PREDEFINED PARAMETERS WITHIN A SURGICAL NETWORK BEFORE        TRANSMISSION;    -   U.S. Provisional Patent Application No. 62/729,176, titled        INDIRECT COMMAND AND CONTROL OF A FIRST OPERATING ROOM SYSTEM        THROUGH THE USE OF A SECOND OPERATING ROOM SYSTEM WITHIN A        STERILE FIELD WHERE THE SECOND OPERATING ROOM SYSTEM HAS PRIMARY        AND SECONDARY OPERATING MODES;    -   U.S. Provisional Patent Application No. 62/729,185, titled        POWERED STAPLING DEVICE THAT IS CAPABLE OF ADJUSTING FORCE,        ADVANCEMENT SPEED, AND OVERALL STROKE OF CUTTING MEMBER OF THE        DEVICE BASED ON SENSED PARAMETER OF FIRING OR CLAMPING;    -   U.S. Provisional Patent Application No. 62/729,184, titled        POWERED SURGICAL TOOL WITH A PREDEFINED ADJUSTABLE CONTROL        ALGORITHM FOR CONTROLLING AT LEAST ONE END EFFECTOR PARAMETER        AND A MEANS FOR LIMITING THE ADJUSTMENT;    -   U.S. Provisional Patent Application No. 62/729,182, titled        SENSING THE PATIENT POSITION AND CONTACT UTILIZING THE MONO        POLAR RETURN PAD ELECTRODE TO PROVIDE SITUATIONAL AWARENESS TO        THE HUB;    -   U.S. Provisional Patent Application No. 62/729,191, titled        SURGICAL NETWORK RECOMMENDATIONS FROM REAL TIME ANALYSIS OF        PROCEDURE VARIABLES AGAINST A BASELINE HIGHLIGHTING DIFFERENCES        FROM THE OPTIMAL SOLUTION;    -   U.S. Provisional Patent Application No. 62/729,195, titled        ULTRASONIC ENERGY DEVICE WHICH VARIES PRESSURE APPLIED BY CLAMP        ARM TO PROVIDE THRESHOLD CONTROL PRESSURE AT A CUT PROGRESSION        LOCATION; and    -   U.S. Provisional Patent Application No. 62/729,186, titled        WIRELESS PAIRING OF A SURGICAL DEVICE WITH ANOTHER DEVICE WITHIN        A STERILE SURGICAL FIELD BASED ON THE USAGE AND SITUATIONAL        AWARENESS OF DEVICES.

Applicant of the present application owns the following U.S. patentapplications, filed on Aug. 28, 2018, the disclosure of each of which isherein incorporated by reference in its entirety:

-   -   U.S. patent application Ser. No. 16/115,214, titled ESTIMATING        STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR;    -   U.S. patent application Ser. No. 16/115,205, titled TEMPERATURE        CONTROL OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR;    -   U.S. patent application Ser. No. 16/115,233, titled RADIO        FREQUENCY ENERGY DEVICE FOR DELIVERING COMBINED ELECTRICAL        SIGNALS;    -   U.S. patent application Ser. No. 16/115,208, titled CONTROLLING        AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO TISSUE LOCATION;    -   U.S. patent application Ser. No. 16/115,220, titled CONTROLLING        ACTIVATION OF AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO THE        PRESENCE OF TISSUE;    -   U.S. patent application Ser. No. 16/115,232, titled DETERMINING        TISSUE COMPOSITION VIA AN ULTRASONIC SYSTEM;    -   U.S. patent application Ser. No. 16/115,239, titled DETERMINING        THE STATE OF AN ULTRASONIC ELECTROMECHANICAL SYSTEM ACCORDING TO        FREQUENCY SHIFT;    -   U.S. patent application Ser. No. 16/115,247, titled DETERMINING        THE STATE OF AN ULTRASONIC END EFFECTOR;    -   U.S. patent application Ser. No. 16/115,211, titled SITUATIONAL        AWARENESS OF ELECTROSURGICAL SYSTEMS;    -   U.S. patent application Ser. No. 16/115,226, titled MECHANISMS        FOR CONTROLLING DIFFERENT ELECTROMECHANICAL SYSTEMS OF AN        ELECTROSURGICAL INSTRUMENT;    -   U.S. patent application Ser. No. 16/115,240, titled DETECTION OF        END EFFECTOR IMMERSION IN LIQUID;    -   U.S. patent application Ser. No. 16/115,249, titled INTERRUPTION        OF ENERGY DUE TO INADVERTENT CAPACITIVE COUPLING;    -   U.S. patent application Ser. No. 16/115,256, titled INCREASING        RADIO FREQUENCY TO CREATE PAD-LESS MONOPOLAR LOOP;    -   U.S. patent application Ser. No. 16/115,223, titled BIPOLAR        COMBINATION DEVICE THAT AUTOMATICALLY ADJUSTS PRESSURE BASED ON        ENERGY MODALITY; and    -   U.S. patent application Ser. No. 16/115,238, titled ACTIVATION        OF ENERGY DEVICES.

Applicant of the present application owns the following U.S. patentapplications, filed on Aug. 23, 2018, the disclosure of each of which isherein incorporated by reference in its entirety:

-   -   U.S. Provisional Patent Application No. 62/721,995, titled        CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO        TISSUE LOCATION;    -   U.S. Provisional Patent Application No. 62/721,998, titled        SITUATIONAL AWARENESS OF ELECTROSURGICAL SYSTEMS;    -   U.S. Provisional Patent Application No. 62/721,999, titled        INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACITIVE COUPLING;    -   U.S. Provisional Patent Application No. 62/721,994, titled        BIPOLAR COMBINATION DEVICE THAT AUTOMATICALLY ADJUSTS PRESSURE        BASED ON ENERGY MODALITY; and    -   U.S. Provisional Patent Application No. 62/721,996, titled RADIO        FREQUENCY ENERGY DEVICE FOR DELIVERING COMBINED ELECTRICAL        SIGNALS.

Applicant of the present application owns the following U.S. patentapplications, filed on Jun. 30, 2018, the disclosure of each of which isherein incorporated by reference in its entirety:

-   -   U.S. Provisional Patent Application No. 62/692,747, titled SMART        ACTIVATION OF AN ENERGY DEVICE BY ANOTHER DEVICE;    -   U.S. Provisional Patent Application No. 62/692,748, titled SMART        ENERGY ARCHITECTURE; and    -   U.S. Provisional Patent Application No. 62/692,768, titled SMART        ENERGY DEVICES.

Applicant of the present application owns the following U.S. patentapplications, filed on Jun. 29, 2018, the disclosure of each of which isherein incorporated by reference in its entirety:

-   -   U.S. patent application Ser. No. 16/024,090, titled CAPACITIVE        COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS;    -   U.S. patent application Ser. No. 16/024,057, titled CONTROLLING        A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE PARAMETERS;    -   U.S. patent application Ser. No. 16/024,067, titled SYSTEMS FOR        ADJUSTING END EFFECTOR PARAMETERS BASED ON PERIOPERATIVE        INFORMATION;    -   U.S. patent application Ser. No. 16/024,075, titled SAFETY        SYSTEMS FOR SMART POWERED SURGICAL STAPLING;    -   U.S. patent application Ser. No. 16/024,083, titled SAFETY        SYSTEMS FOR SMART POWERED SURGICAL STAPLING;    -   U.S. patent application Ser. No. 16/024,094, titled SURGICAL        SYSTEMS FOR DETECTING END EFFECTOR TISSUE DISTRIBUTION        IRREGULARITIES;    -   U.S. patent application Ser. No. 16/024,138, titled SYSTEMS FOR        DETECTING PROXIMITY OF SURGICAL END EFFECTOR TO CANCEROUS        TISSUE;    -   U.S. patent application Ser. No. 16/024,150, titled SURGICAL        INSTRUMENT CARTRIDGE SENSOR ASSEMBLIES;    -   U.S. patent application Ser. No. 16/024,160, titled VARIABLE        OUTPUT CARTRIDGE SENSOR ASSEMBLY;    -   U.S. patent application Ser. No. 16/024,124, titled SURGICAL        INSTRUMENT HAVING A FLEXIBLE ELECTRODE;    -   U.S. patent application Ser. No. 16/024,132, titled SURGICAL        INSTRUMENT HAVING A FLEXIBLE CIRCUIT;    -   U.S. patent application Ser. No. 16/024,141, titled SURGICAL        INSTRUMENT WITH A TISSUE MARKING ASSEMBLY;    -   U.S. patent application Ser. No. 16/024,162, titled SURGICAL        SYSTEMS WITH PRIORITIZED DATA TRANSMISSION CAPABILITIES;    -   U.S. patent application Ser. No. 16/024,066, titled SURGICAL        EVACUATION SENSING AND MOTOR CONTROL;    -   U.S. patent application Ser. No. 16/024,096, titled SURGICAL        EVACUATION SENSOR ARRANGEMENTS;    -   U.S. patent application Ser. No. 16/024,116, titled SURGICAL        EVACUATION FLOW PATHS;    -   U.S. patent application Ser. No. 16/024,149, titled SURGICAL        EVACUATION SENSING AND GENERATOR CONTROL;    -   U.S. patent application Ser. No. 16/024,180, titled SURGICAL        EVACUATION SENSING AND DISPLAY;    -   U.S. patent application Ser. No. 16/024,245, titled        COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR        CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL        PLATFORM;    -   U.S. patent application Ser. No. 16/024,258, titled SMOKE        EVACUATION SYSTEM INCLUDING A SEGMENTED CONTROL CIRCUIT FOR        INTERACTIVE SURGICAL PLATFORM;    -   U.S. patent application Ser. No. 16/024,265, titled SURGICAL        EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION        BETWEEN A FILTER AND A SMOKE EVACUATION DEVICE; and    -   U.S. patent application Ser. No. 16/024,273, titled DUAL        IN-SERIES LARGE AND SMALL DROPLET FILTERS.

Applicant of the present application owns the following U.S. Provisionalpatent applications, filed on Jun. 28, 2018, the disclosure of each ofwhich is herein incorporated by reference in its entirety:

-   -   U.S. Provisional Patent Application Ser. No. 62/691,228, titled        A METHOD OF USING REINFORCED FLEX CIRCUITS WITH MULTIPLE SENSORS        WITH ELECTROSURGICAL DEVICES;    -   U.S. Provisional Patent Application Ser. No. 62/691,227, titled        CONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE        PARAMETERS;    -   U.S. Provisional Patent Application Ser. No. 62/691,230, titled        SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE;    -   U.S. Provisional Patent Application Ser. No. 62/691,219, titled        SURGICAL EVACUATION SENSING AND MOTOR CONTROL;    -   U.S. Provisional Patent Application Ser. No. 62/691,257, titled        COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR        CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL        PLATFORM;    -   U.S. Provisional Patent Application Ser. No. 62/691,262, titled        SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR        COMMUNICATION BETWEEN A FILTER AND A SMOKE EVACUATION DEVICE;        and    -   U.S. Provisional Patent Application Ser. No. 62/691,251, titled        DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS.

Applicant of the present application owns the following U.S. Provisionalpatent application, filed on Apr. 19, 2018, the disclosure of which isherein incorporated by reference in its entirety:

-   -   U.S. Provisional Patent Application Ser. No. 62/659,900, titled        METHOD OF HUB COMMUNICATION.

Applicant of the present application owns the following U.S. Provisionalpatent applications, filed on Mar. 30, 2018, the disclosure of each ofwhich is herein incorporated by reference in its entirety:

-   -   U.S. Provisional Patent Application No. 62/650,898 filed on Mar.        30, 2018, titled CAPACITIVE COUPLED RETURN PATH PAD WITH        SEPARABLE ARRAY ELEMENTS;    -   U.S. Provisional Patent Application Ser. No. 62/650,887, titled        SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES;    -   U.S. Provisional Patent Application Ser. No. 62/650,882, titled        SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM; and    -   U.S. Provisional Patent Application Ser. No. 62/650,877, titled        SURGICAL SMOKE EVACUATION SENSING AND CONTROLS.

Applicant of the present application owns the following U.S. patentapplications, filed on Mar. 29, 2018, the disclosure of each of which isherein incorporated by reference in its entirety:

-   -   U.S. patent application Ser. No. 15/940,641, titled INTERACTIVE        SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES;    -   U.S. patent application Ser. No. 15/940,648, titled INTERACTIVE        SURGICAL SYSTEMS WITH CONDITION HANDLING OF DEVICES AND DATA        CAPABILITIES;    -   U.S. patent application Ser. No. 15/940,656, titled SURGICAL HUB        COORDINATION OF CONTROL AND COMMUNICATION OF OPERATING ROOM        DEVICES;    -   U.S. patent application Ser. No. 15/940,666, titled SPATIAL        AWARENESS OF SURGICAL HUBS IN OPERATING ROOMS;    -   U.S. patent application Ser. No. 15/940,670, titled COOPERATIVE        UTILIZATION OF DATA DERIVED FROM SECONDARY SOURCES BY        INTELLIGENT SURGICAL HUBS;    -   U.S. patent application Ser. No. 15/940,677, titled SURGICAL HUB        CONTROL ARRANGEMENTS;    -   U.S. patent application Ser. No. 15/940,632, titled DATA        STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE        ANONYMIZED RECORD;    -   U.S. patent application Ser. No. 15/940,640, titled        COMMUNICATION HUB AND STORAGE DEVICE FOR STORING PARAMETERS AND        STATUS OF A SURGICAL DEVICE TO BE SHARED WITH CLOUD BASED        ANALYTICS SYSTEMS;    -   U.S. patent application Ser. No. 15/940,645, titled SELF        DESCRIBING DATA PACKETS GENERATED AT AN ISSUING INSTRUMENT;    -   U.S. patent application Ser. No. 15/940,649, titled DATA PAIRING        TO INTERCONNECT A DEVICE MEASURED PARAMETER WITH AN OUTCOME;    -   U.S. patent application Ser. No. 15/940,654, titled SURGICAL HUB        SITUATIONAL AWARENESS;    -   U.S. patent application Ser. No. 15/940,663, titled SURGICAL        SYSTEM DISTRIBUTED PROCESSING;    -   U.S. patent application Ser. No. 15/940,668, titled AGGREGATION        AND REPORTING OF SURGICAL HUB DATA;    -   U.S. patent application Ser. No. 15/940,671, titled SURGICAL HUB        SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER;    -   U.S. patent application Ser. No. 15/940,686, titled DISPLAY OF        ALIGNMENT OF STAPLE CARTRIDGE TO PRIOR LINEAR STAPLE LINE;    -   U.S. patent application Ser. No. 15/940,700, titled STERILE        FIELD INTERACTIVE CONTROL DISPLAYS;    -   U.S. patent application Ser. No. 15/940,629, titled COMPUTER        IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS;    -   U.S. patent application Ser. No. 15/940,704, titled USE OF LASER        LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF        BACK SCATTERED LIGHT;    -   U.S. patent application Ser. No. 15/940,722, titled        CHARACTERIZATION OF TISSUE IRREGULARITIES THROUGH THE USE OF        MONO-CHROMATIC LIGHT REFRACTIVITY;    -   U.S. patent application Ser. No. 15/940,742, titled DUAL CMOS        ARRAY IMAGING.    -   U.S. patent application Ser. No. 15/940,636, titled ADAPTIVE        CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES;    -   U.S. patent application Ser. No. 15/940,653, titled ADAPTIVE        CONTROL PROGRAM UPDATES FOR SURGICAL HUBS;    -   U.S. patent application Ser. No. 15/940,660, titled CLOUD-BASED        MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A        USER;    -   U.S. patent application Ser. No. 15/940,679, titled CLOUD-BASED        MEDICAL ANALYTICS FOR LINKING OF LOCAL USAGE TRENDS WITH THE        RESOURCE ACQUISITION BEHAVIORS OF LARGER DATA SET;    -   U.S. patent application Ser. No. 15/940,694, titled CLOUD-BASED        MEDICAL ANALYTICS FOR MEDICAL FACILITY SEGMENTED        INDIVIDUALIZATION OF INSTRUMENT FUNCTION;    -   U.S. patent application Ser. No. 15/940,634, titled CLOUD-BASED        MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND        REACTIVE MEASURES;    -   U.S. patent application Ser. No. 15/940,706, titled DATA        HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK;    -   U.S. patent application Ser. No. 15/940,675, titled CLOUD        INTERFACE FOR COUPLED SURGICAL DEVICES;    -   U.S. patent application Ser. No. 15/940,627, titled DRIVE        ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;    -   U.S. patent application Ser. No. 15/940,637, titled        COMMUNICATION ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL        PLATFORMS;    -   U.S. patent application Ser. No. 15/940,642, titled CONTROLS FOR        ROBOT-ASSISTED SURGICAL PLATFORMS;    -   U.S. patent application Ser. No. 15/940,676, titled AUTOMATIC        TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;    -   U.S. patent application Ser. No. 15/940,680, titled CONTROLLERS        FOR ROBOT-ASSISTED SURGICAL PLATFORMS;    -   U.S. patent application Ser. No. 15/940,683, titled COOPERATIVE        SURGICAL ACTIONS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;    -   U.S. patent application Ser. No. 15/940,690, titled DISPLAY        ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS; and    -   U.S. patent application Ser. No. 15/940,711, titled SENSING        ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS.

Applicant of the present application owns the following U.S. Provisionalpatent applications, filed on Mar. 28, 2018, the disclosure of each ofwhich is herein incorporated by reference in its entirety:

-   -   U.S. Provisional Patent Application Ser. No. 62/649,302, titled        INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION        CAPABILITIES;    -   U.S. Provisional Patent Application Ser. No. 62/649,294, titled        DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE        ANONYMIZED RECORD;    -   U.S. Provisional Patent Application Ser. No. 62/649,300, titled        SURGICAL HUB SITUATIONAL AWARENESS;    -   U.S. Provisional Patent Application Ser. No. 62/649,309, titled        SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING        THEATER;    -   U.S. Provisional Patent Application Ser. No. 62/649,310, titled        COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS;    -   U.S. Provisional Patent Application Ser. No. 62/649,291, titled        USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE        PROPERTIES OF BACK SCATTERED LIGHT;    -   U.S. Provisional Patent Application Ser. No. 62/649,296, titled        ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES;    -   U.S. Provisional Patent Application Ser. No. 62/649,333, titled        CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND        RECOMMENDATIONS TO A USER;    -   U.S. Provisional Patent Application Ser. No. 62/649,327, titled        CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION        TRENDS AND REACTIVE MEASURES;    -   U.S. Provisional Patent Application Ser. No. 62/649,315, titled        DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK;    -   U.S. Provisional Patent Application Ser. No. 62/649,313, titled        CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES;    -   U.S. Provisional Patent Application Ser. No. 62/649,320, titled        DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;    -   U.S. Provisional Patent Application Ser. No. 62/649,307, titled        AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL        PLATFORMS; and    -   U.S. Provisional Patent Application Ser. No. 62/649,323, titled        SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS.

Applicant of the present application owns the following U.S. Provisionalpatent applications, filed on Mar. 8, 2018, the disclosure of each ofwhich is herein incorporated by reference in its entirety:

-   -   U.S. Provisional Patent Application Ser. No. 62/640,417, titled        TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM        THEREFOR; and    -   U.S. Provisional Patent Application Ser. No. 62/640,415, titled        ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM        THEREFOR.

Applicant of the present application owns the following U.S. Provisionalpatent applications, filed on Dec. 28, 2017, the disclosure of each ofwhich is herein incorporated by reference in its entirety:

-   -   U.S. Provisional patent application Serial No. U.S. Provisional        Patent Application Ser. No. 62/611,341, titled INTERACTIVE        SURGICAL PLATFORM;    -   U.S. Provisional Patent Application Ser. No. 62/611,340, titled        CLOUD-BASED MEDICAL ANALYTICS; and    -   U.S. Provisional Patent Application Ser. No. 62/611,339, titled        ROBOT ASSISTED SURGICAL PLATFORM.

Before explaining various aspects of surgical devices and generators indetail, it should be noted that the illustrative examples are notlimited in application or use to the details of construction andarrangement of parts illustrated in the accompanying drawings anddescription. The illustrative examples may be implemented orincorporated in other aspects, variations and modifications, and may bepracticed or carried out in various ways. Further, unless otherwiseindicated, the terms and expressions employed herein have been chosenfor the purpose of describing the illustrative examples for theconvenience of the reader and are not for the purpose of limitationthereof. Also, it will be appreciated that one or more of thefollowing-described aspects, expressions of aspects, and/or examples,can be combined with any one or more of the other following-describedaspects, expressions of aspects and/or examples.

Surgical Hubs

Referring to FIG. 1, a computer-implemented interactive surgical system100 includes one or more surgical systems 102 and a cloud-based system(e.g., the cloud 104 that may include a remote server 113 coupled to astorage device 105). Each surgical system 102 includes at least onesurgical hub 106 in communication with the cloud 104 that may include aremote server 113. In one example, as illustrated in FIG. 1, thesurgical system 102 includes a visualization system 108, a roboticsystem 110, and a handheld intelligent surgical instrument 112, whichare configured to communicate with one another and/or the hub 106. Insome aspects, a surgical system 102 may include an M number of hubs 106,an N number of visualization systems 108, an O number of robotic systems110, and a P number of handheld intelligent surgical instruments 112,where M, N, O, and P are integers greater than or equal to one.

FIG. 2 depicts an example of a surgical system 102 being used to performa surgical procedure on a patient who is lying down on an operatingtable 114 in a surgical operating room 116. A robotic system 110 is usedin the surgical procedure as a part of the surgical system 102. Therobotic system 110 includes a surgeon's console 118, a patient side cart120 (surgical robot), and a surgical robotic hub 122. The patient sidecart 120 can manipulate at least one removably coupled surgical tool 117through a minimally invasive incision in the body of the patient whilethe surgeon views the surgical site through the surgeon's console 118.An image of the surgical site can be obtained by a medical imagingdevice 124, which can be manipulated by the patient side cart 120 toorient the imaging device 124. The robotic hub 122 can be used toprocess the images of the surgical site for subsequent display to thesurgeon through the surgeon's console 118.

Other types of robotic systems can be readily adapted for use with thesurgical system 102. Various examples of robotic systems and surgicaltools that are suitable for use with the present disclosure aredescribed in U.S. Provisional Patent Application Ser. No. 62/611,339,titled ROBOT ASSISTED SURGICAL PLATFORM, filed Dec. 28, 2017, thedisclosure of which is herein incorporated by reference in its entirety.

Various examples of cloud-based analytics that are performed by thecloud 104, and are suitable for use with the present disclosure, aredescribed in U.S. Provisional Patent Application Ser. No. 62/611,340,titled CLOUD-BASED MEDICAL ANALYTICS, filed Dec. 28, 2017, thedisclosure of which is herein incorporated by reference in its entirety.

In various aspects, the imaging device 124 includes at least one imagesensor and one or more optical components. Suitable image sensorsinclude, but are not limited to, Charge-Coupled Device (CCD) sensors andComplementary Metal-Oxide Semiconductor (CMOS) sensors.

The optical components of the imaging device 124 may include one or moreillumination sources and/or one or more lenses. The one or moreillumination sources may be directed to illuminate portions of thesurgical field. The one or more image sensors may receive lightreflected or refracted from the surgical field, including lightreflected or refracted from tissue and/or surgical instruments.

The one or more illumination sources may be configured to radiateelectromagnetic energy in the visible spectrum as well as the invisiblespectrum. The visible spectrum, sometimes referred to as the opticalspectrum or luminous spectrum, is that portion of the electromagneticspectrum that is visible to (i.e., can be detected by) the human eye andmay be referred to as visible light or simply light. A typical human eyewill respond to wavelengths in air that are from about 380 nm to about750 nm.

The invisible spectrum (i.e., the non-luminous spectrum) is that portionof the electromagnetic spectrum that lies below and above the visiblespectrum (i.e., wavelengths below about 380 nm and above about 750 nm).The invisible spectrum is not detectable by the human eye. Wavelengthsgreater than about 750 nm are longer than the red visible spectrum, andthey become invisible infrared (IR), microwave, and radioelectromagnetic radiation. Wavelengths less than about 380 nm areshorter than the violet spectrum, and they become invisible ultraviolet,x-ray, and gamma ray electromagnetic radiation.

In various aspects, the imaging device 124 is configured for use in aminimally invasive procedure. Examples of imaging devices suitable foruse with the present disclosure include, but not limited to, anarthroscope, angioscope, bronchoscope, choledochoscope, colonoscope,cytoscope, duodenoscope, enteroscope, esophagogastro-duodenoscope(gastroscope), endoscope, laryngoscope, nasopharyngo-neproscope,sigmoidoscope, thoracoscope, and ureteroscope.

In one aspect, the imaging device employs multi-spectrum monitoring todiscriminate topography and underlying structures. A multi-spectralimage is one that captures image data within specific wavelength rangesacross the electromagnetic spectrum. The wavelengths may be separated byfilters or by the use of instruments that are sensitive to particularwavelengths, including light from frequencies beyond the visible lightrange, e.g., IR and ultraviolet. Spectral imaging can allow extractionof additional information the human eye fails to capture with itsreceptors for red, green, and blue. The use of multi-spectral imaging isdescribed in greater detail under the heading “Advanced ImagingAcquisition Module” in U.S. Provisional Patent Application Ser. No.62/611,341, titled INTERACTIVE SURGICAL PLATFORM, filed Dec. 28, 2017,the disclosure of which is herein incorporated by reference in itsentirety. Multi-spectrum monitoring can be a useful tool in relocating asurgical field after a surgical task is completed to perform one or moreof the previously described tests on the treated tissue.

It is axiomatic that strict sterilization of the operating room andsurgical equipment is required during any surgery. The strict hygieneand sterilization conditions required in a “surgical theater,” i.e., anoperating or treatment room, necessitate the highest possible sterilityof all medical devices and equipment. Part of that sterilization processis the need to sterilize anything that comes in contact with the patientor penetrates the sterile field, including the imaging device 124 andits attachments and components. It will be appreciated that the sterilefield may be considered a specified area, such as within a tray or on asterile towel, that is considered free of microorganisms, or the sterilefield may be considered an area, immediately around a patient, who hasbeen prepared for a surgical procedure. The sterile field may includethe scrubbed team members, who are properly attired, and all furnitureand fixtures in the area.

In various aspects, the visualization system 108 includes one or moreimaging sensors, one or more image-processing units, one or more storagearrays, and one or more displays that are strategically arranged withrespect to the sterile field, as illustrated in FIG. 2. In one aspect,the visualization system 108 includes an interface for HL7, PACS, andEMR. Various components of the visualization system 108 are describedunder the heading “Advanced Imaging Acquisition Module” in U.S.Provisional Patent Application Ser. No. 62/611,341, titled INTERACTIVESURGICAL PLATFORM, filed Dec. 28, 2017, the disclosure of which isherein incorporated by reference in its entirety.

As illustrated in FIG. 2, a primary display 119 is positioned in thesterile field to be visible to an operator at the operating table 114.In addition, a visualization tower 111 is positioned outside the sterilefield. The visualization tower 111 includes a first non-sterile display107 and a second non-sterile display 109, which face away from eachother. The visualization system 108, guided by the hub 106, isconfigured to utilize the displays 107, 109, and 119 to coordinateinformation flow to operators inside and outside the sterile field. Forexample, the hub 106 may cause the visualization system 108 to display asnapshot of a surgical site, as recorded by an imaging device 124, on anon-sterile display 107 or 109, while maintaining a live feed of thesurgical site on the primary display 119. The snapshot on thenon-sterile display 107 or 109 can permit a non-sterile operator toperform a diagnostic step relevant to the surgical procedure, forexample.

In one aspect, the hub 106 is also configured to route a diagnosticinput or feedback entered by a non-sterile operator at the visualizationtower 111 to the primary display 119 within the sterile field, where itcan be viewed by a sterile operator at the operating table. In oneexample, the input can be in the form of a modification to the snapshotdisplayed on the non-sterile display 107 or 109, which can be routed tothe primary display 119 by the hub 106.

Referring to FIG. 2, a surgical instrument 112 is being used in thesurgical procedure as part of the surgical system 102. The hub 106 isalso configured to coordinate information flow to a display of thesurgical instrument 112. For example, coordinate information flow isfurther described in U.S. Provisional Patent Application Ser. No.62/611,341, titled INTERACTIVE SURGICAL PLATFORM, filed Dec. 28, 2017,the disclosure of which is herein incorporated by reference in itsentirety. A diagnostic input or feedback entered by a non-sterileoperator at the visualization tower 111 can be routed by the hub 106 tothe surgical instrument display 115 within the sterile field, where itcan be viewed by the operator of the surgical instrument 112. Examplesurgical instruments that are suitable for use with the surgical system102 are described under the heading “Surgical Instrument Hardware” inU.S. Provisional Patent Application Ser. No. 62/611,341, titledINTERACTIVE SURGICAL PLATFORM, filed Dec. 28, 2017, the disclosure ofwhich is herein incorporated by reference in its entirety, for example.

Referring now to FIG. 3, a hub 106 is depicted in communication with avisualization system 108, a robotic system 110, and a handheldintelligent surgical instrument 112. The hub 106 includes a hub display135, an imaging module 138, a generator module 140 (which can include amonopolar generator 142, a bipolar generator 144, and/or an ultrasonicgenerator 143), a communication module 130, a processor module 132, anda storage array 134. In certain aspects, as illustrated in FIG. 3, thehub 106 further includes a smoke evacuation module 126, asuction/irrigation module 128, and/or an OR mapping module 133.

During a surgical procedure, energy application to tissue, for sealingand/or cutting, is generally associated with smoke evacuation, suctionof excess fluid, and/or irrigation of the tissue. Fluid, power, and/ordata lines from different sources are often entangled during thesurgical procedure. Valuable time can be lost addressing this issueduring a surgical procedure. Detangling the lines may necessitatedisconnecting the lines from their respective modules, which may requireresetting the modules. The hub modular enclosure 136 offers a unifiedenvironment for managing the power, data, and fluid lines, which reducesthe frequency of entanglement between such lines.

Aspects of the present disclosure present a surgical hub for use in asurgical procedure that involves energy application to tissue at asurgical site. The surgical hub includes a hub enclosure and a combogenerator module slidably receivable in a docking station of the hubenclosure. The docking station includes data and power contacts. Thecombo generator module includes two or more of an ultrasonic energygenerator component, a bipolar RF energy generator component, and amonopolar RF energy generator component that are housed in a singleunit. In one aspect, the combo generator module also includes a smokeevacuation component, at least one energy delivery cable for connectingthe combo generator module to a surgical instrument, at least one smokeevacuation component configured to evacuate smoke, fluid, and/orparticulates generated by the application of therapeutic energy to thetissue, and a fluid line extending from the remote surgical site to thesmoke evacuation component.

In one aspect, the fluid line is a first fluid line and a second fluidline extends from the remote surgical site to a suction and irrigationmodule slidably received in the hub enclosure. In one aspect, the hubenclosure comprises a fluid interface.

Certain surgical procedures may require the application of more than oneenergy type to the tissue. One energy type may be more beneficial forcutting the tissue, while another different energy type may be morebeneficial for sealing the tissue. For example, a bipolar generator canbe used to seal the tissue while an ultrasonic generator can be used tocut the sealed tissue. Aspects of the present disclosure present asolution where a hub modular enclosure 136 is configured to accommodatedifferent generators, and facilitate an interactive communicationtherebetween. One of the advantages of the hub modular enclosure 136 isenabling the quick removal and/or replacement of various modules.

Aspects of the present disclosure present a modular surgical enclosurefor use in a surgical procedure that involves energy application totissue. The modular surgical enclosure includes a first energy-generatormodule, configured to generate a first energy for application to thetissue, and a first docking station comprising a first docking port thatincludes first data and power contacts, wherein the firstenergy-generator module is slidably movable into an electricalengagement with the power and data contacts and wherein the firstenergy-generator module is slidably movable out of the electricalengagement with the first power and data contacts,

Further to the above, the modular surgical enclosure also includes asecond energy-generator module configured to generate a second energy,different than the first energy, for application to the tissue, and asecond docking station comprising a second docking port that includessecond data and power contacts, wherein the second energy-generatormodule is slidably movable into an electrical engagement with the powerand data contacts, and wherein the second energy-generator module isslidably movable out of the electrical engagement with the second powerand data contacts.

In addition, the modular surgical enclosure also includes acommunication bus between the first docking port and the second dockingport, configured to facilitate communication between the firstenergy-generator module and the second energy-generator module.

Referring to FIGS. 3-7, aspects of the present disclosure are presentedfor a hub modular enclosure 136 that allows the modular integration of agenerator module 140, a smoke evacuation module 126, and asuction/irrigation module 128. The hub modular enclosure 136 furtherfacilitates interactive communication between the modules 140, 126, 128.As illustrated in FIG. 5, the generator module 140 can be a generatormodule with integrated monopolar, bipolar, and ultrasonic componentssupported in a single housing unit 139 slidably insertable into the hubmodular enclosure 136. As illustrated in FIG. 5, the generator module140 can be configured to connect to a monopolar device 146, a bipolardevice 147, and an ultrasonic device 148. Alternatively, the generatormodule 140 may comprise a series of monopolar, bipolar, and/orultrasonic generator modules that interact through the hub modularenclosure 136. The hub modular enclosure 136 can be configured tofacilitate the insertion of multiple generators and interactivecommunication between the generators docked into the hub modularenclosure 136 so that the generators would act as a single generator.

In one aspect, the hub modular enclosure 136 comprises a modular powerand communication backplane 149 with external and wireless communicationheaders to enable the removable attachment of the modules 140, 126, 128and interactive communication therebetween.

In one aspect, the hub modular enclosure 136 includes docking stations,or drawers, 151, herein also referred to as drawers, which areconfigured to slidably receive the modules 140, 126, 128. FIG. 4illustrates a partial perspective view of a surgical hub enclosure 136,and a combo generator module 145 slidably receivable in a dockingstation 151 of the surgical hub enclosure 136. A docking port 152 withpower and data contacts on a rear side of the combo generator module 145is configured to engage a corresponding docking port 150 with power anddata contacts of a corresponding docking station 151 of the hub modularenclosure 136 as the combo generator module 145 is slid into positionwithin the corresponding docking station 151 of the hub module enclosure136. In one aspect, the combo generator module 145 includes a bipolar,ultrasonic, and monopolar module and a smoke evacuation moduleintegrated together into a single housing unit 139, as illustrated inFIG. 5.

In various aspects, the smoke evacuation module 126 includes a fluidline 154 that conveys captured/collected smoke and/or fluid away from asurgical site and to, for example, the smoke evacuation module 126.Vacuum suction originating from the smoke evacuation module 126 can drawthe smoke into an opening of a utility conduit at the surgical site. Theutility conduit, coupled to the fluid line, can be in the form of aflexible tube terminating at the smoke evacuation module 126. Theutility conduit and the fluid line define a fluid path extending towardthe smoke evacuation module 126 that is received in the hub enclosure136.

In various aspects, the suction/irrigation module 128 is coupled to asurgical tool comprising an aspiration fluid line and a suction fluidline. In one example, the aspiration and suction fluid lines are in theform of flexible tubes extending from the surgical site toward thesuction/irrigation module 128. One or more drive systems can beconfigured to cause irrigation and aspiration of fluids to and from thesurgical site.

In one aspect, the surgical tool includes a shaft having an end effectorat a distal end thereof and at least one energy treatment associatedwith the end effector, an aspiration tube, and an irrigation tube. Theaspiration tube can have an inlet port at a distal end thereof and theaspiration tube extends through the shaft. Similarly, an irrigation tubecan extend through the shaft and can have an inlet port in proximity tothe energy deliver implement. The energy deliver implement is configuredto deliver ultrasonic and/or RF energy to the surgical site and iscoupled to the generator module 140 by a cable extending initiallythrough the shaft.

The irrigation tube can be in fluid communication with a fluid source,and the aspiration tube can be in fluid communication with a vacuumsource. The fluid source and/or the vacuum source can be housed in thesuction/irrigation module 128. In one example, the fluid source and/orthe vacuum source can be housed in the hub enclosure 136 separately fromthe suction/irrigation module 128. In such example, a fluid interfacecan be configured to connect the suction/irrigation module 128 to thefluid source and/or the vacuum source.

In one aspect, the modules 140, 126, 128 and/or their correspondingdocking stations on the hub modular enclosure 136 may include alignmentfeatures that are configured to align the docking ports of the modulesinto engagement with their counterparts in the docking stations of thehub modular enclosure 136. For example, as illustrated in FIG. 4, thecombo generator module 145 includes side brackets 155 that areconfigured to slidably engage with corresponding brackets 156 of thecorresponding docking station 151 of the hub modular enclosure 136. Thebrackets cooperate to guide the docking port contacts of the combogenerator module 145 into an electrical engagement with the docking portcontacts of the hub modular enclosure 136.

In some aspects, the drawers 151 of the hub modular enclosure 136 arethe same, or substantially the same size, and the modules are adjustedin size to be received in the drawers 151. For example, the sidebrackets 155 and/or 156 can be larger or smaller depending on the sizeof the module. In other aspects, the drawers 151 are different in sizeand are each designed to accommodate a particular module.

Furthermore, the contacts of a particular module can be keyed forengagement with the contacts of a particular drawer to avoid inserting amodule into a drawer with mismatching contacts.

As illustrated in FIG. 4, the docking port 150 of one drawer 151 can becoupled to the docking port 150 of another drawer 151 through acommunications link 157 to facilitate an interactive communicationbetween the modules housed in the hub modular enclosure 136. The dockingports 150 of the hub modular enclosure 136 may alternatively, oradditionally, facilitate a wireless interactive communication betweenthe modules housed in the hub modular enclosure 136. Any suitablewireless communication can be employed, such as for example AirTitan-Bluetooth.

FIG. 6 illustrates individual power bus attachments for a plurality oflateral docking ports of a lateral modular housing 160 configured toreceive a plurality of modules of a surgical hub 206. The lateralmodular housing 160 is configured to laterally receive and interconnectthe modules 161. The modules 161 are slidably inserted into dockingstations 162 of lateral modular housing 160, which includes a backplanefor interconnecting the modules 161. As illustrated in FIG. 6, themodules 161 are arranged laterally in the lateral modular housing 160.Alternatively, the modules 161 may be arranged vertically in a lateralmodular housing.

FIG. 7 illustrates a vertical modular housing 164 configured to receivea plurality of modules 165 of the surgical hub 106. The modules 165 areslidably inserted into docking stations, or drawers, 167 of verticalmodular housing 164, which includes a backplane for interconnecting themodules 165. Although the drawers 167 of the vertical modular housing164 are arranged vertically, in certain instances, a vertical modularhousing 164 may include drawers that are arranged laterally.Furthermore, the modules 165 may interact with one another through thedocking ports of the vertical modular housing 164. In the example ofFIG. 7, a display 177 is provided for displaying data relevant to theoperation of the modules 165. In addition, the vertical modular housing164 includes a master module 178 housing a plurality of sub-modules thatare slidably received in the master module 178.

In various aspects, the imaging module 138 comprises an integrated videoprocessor and a modular light source and is adapted for use with variousimaging devices. In one aspect, the imaging device is comprised of amodular housing that can be assembled with a light source module and acamera module. The housing can be a disposable housing. In at least oneexample, the disposable housing is removably coupled to a reusablecontroller, a light source module, and a camera module. The light sourcemodule and/or the camera module can be selectively chosen depending onthe type of surgical procedure. In one aspect, the camera modulecomprises a CCD sensor. In another aspect, the camera module comprises aCMOS sensor. In another aspect, the camera module is configured forscanned beam imaging. Likewise, the light source module can beconfigured to deliver a white light or a different light, depending onthe surgical procedure.

During a surgical procedure, removing a surgical device from thesurgical field and replacing it with another surgical device thatincludes a different camera or a different light source can beinefficient. Temporarily losing sight of the surgical field may lead toundesirable consequences. The module imaging device of the presentdisclosure is configured to permit the replacement of a light sourcemodule or a camera module midstream during a surgical procedure, withouthaving to remove the imaging device from the surgical field.

In one aspect, the imaging device comprises a tubular housing thatincludes a plurality of channels. A first channel is configured toslidably receive the camera module, which can be configured for asnap-fit engagement with the first channel. A second channel isconfigured to slidably receive the light source module, which can beconfigured for a snap-fit engagement with the second channel. In anotherexample, the camera module and/or the light source module can be rotatedinto a final position within their respective channels. A threadedengagement can be employed in lieu of the snap-fit engagement.

In various examples, multiple imaging devices are placed at differentpositions in the surgical field to provide multiple views. The imagingmodule 138 can be configured to switch between the imaging devices toprovide an optimal view. In various aspects, the imaging module 138 canbe configured to integrate the images from the different imaging device.

Various image processors and imaging devices suitable for use with thepresent disclosure are described in U.S. Pat. No. 7,995,045, titledCOMBINED SBI AND CONVENTIONAL IMAGE PROCESSOR, which issued on Aug. 9,2011, which is herein incorporated by reference in its entirety. Inaddition, U.S. Pat. No. 7,982,776, titled SBI MOTION ARTIFACT REMOVALAPPARATUS AND METHOD, which issued on Jul. 19, 2011, which is hereinincorporated by reference in its entirety, describes various systems forremoving motion artifacts from image data. Such systems can beintegrated with the imaging module 138. Furthermore, U.S. PatentApplication Publication No. 2011/0306840, titled CONTROLLABLE MAGNETICSOURCE TO FIXTURE INTRACORPOREAL APPARATUS, which published on Dec. 15,2011, and U.S. Patent Application Publication No. 2014/0243597, titledSYSTEM FOR PERFORMING A MINIMALLY INVASIVE SURGICAL PROCEDURE, whichpublished on Aug. 28, 2014, each of which is herein incorporated byreference in its entirety.

FIG. 8 illustrates a surgical data network 201 comprising a modularcommunication hub 203 configured to connect modular devices located inone or more operating theaters of a healthcare facility, or any room ina healthcare facility specially equipped for surgical operations, to acloud-based system (e.g., the cloud 204 that may include a remote server213 coupled to a storage device 205). In one aspect, the modularcommunication hub 203 comprises a network hub 207 and/or a networkswitch 209 in communication with a network router. The modularcommunication hub 203 also can be coupled to a local computer system 210to provide local computer processing and data manipulation. The surgicaldata network 201 may be configured as passive, intelligent, orswitching. A passive surgical data network serves as a conduit for thedata, enabling it to go from one device (or segment) to another and tothe cloud computing resources. An intelligent surgical data networkincludes additional features to enable the traffic passing through thesurgical data network to be monitored and to configure each port in thenetwork hub 207 or network switch 209. An intelligent surgical datanetwork may be referred to as a manageable hub or switch. A switchinghub reads the destination address of each packet and then forwards thepacket to the correct port.

Modular devices 1 a-1 n located in the operating theater may be coupledto the modular communication hub 203. The network hub 207 and/or thenetwork switch 209 may be coupled to a network router 211 to connect thedevices 1 a-1 n to the cloud 204 or the local computer system 210. Dataassociated with the devices 1 a-1 n may be transferred to cloud-basedcomputers via the router for remote data processing and manipulation.Data associated with the devices 1 a-1 n may also be transferred to thelocal computer system 210 for local data processing and manipulation.Modular devices 2 a-2 m located in the same operating theater also maybe coupled to a network switch 209. The network switch 209 may becoupled to the network hub 207 and/or the network router 211 to connectto the devices 2 a-2 m to the cloud 204. Data associated with thedevices 2 a-2 n may be transferred to the cloud 204 via the networkrouter 211 for data processing and manipulation. Data associated withthe devices 2 a-2 m may also be transferred to the local computer system210 for local data processing and manipulation.

It will be appreciated that the surgical data network 201 may beexpanded by interconnecting multiple network hubs 207 and/or multiplenetwork switches 209 with multiple network routers 211. The modularcommunication hub 203 may be contained in a modular control towerconfigured to receive multiple devices 1 a-1 n/2 a-2 m. The localcomputer system 210 also may be contained in a modular control tower.The modular communication hub 203 is connected to a display 212 todisplay images obtained by some of the devices 1 a-1 n/2 a-2 m, forexample during surgical procedures. In various aspects, the devices 1a-1 n/2 a-2 m may include, for example, various modules such as animaging module 138 coupled to an endoscope, a generator module 140coupled to an energy-based surgical device, a smoke evacuation module126, a suction/irrigation module 128, a communication module 130, aprocessor module 132, a storage array 134, a surgical device coupled toa display, and/or a non-contact sensor module, among other modulardevices that may be connected to the modular communication hub 203 ofthe surgical data network 201.

In one aspect, the surgical data network 201 may comprise a combinationof network hub(s), network switch(es), and network router(s) connectingthe devices 1 a-1 n/2 a-2 m to the cloud. Any one of or all of thedevices 1 a-1 n/2 a-2 m coupled to the network hub or network switch maycollect data in real time and transfer the data to cloud computers fordata processing and manipulation. It will be appreciated that cloudcomputing relies on sharing computing resources rather than having localservers or personal devices to handle software applications. The word“cloud” may be used as a metaphor for “the Internet,” although the termis not limited as such. Accordingly, the term “cloud computing” may beused herein to refer to “a type of Internet-based computing,” wheredifferent services—such as servers, storage, and applications—aredelivered to the modular communication hub 203 and/or computer system210 located in the surgical theater (e.g., a fixed, mobile, temporary,or field operating room or space) and to devices connected to themodular communication hub 203 and/or computer system 210 through theInternet. The cloud infrastructure may be maintained by a cloud serviceprovider. In this context, the cloud service provider may be the entitythat coordinates the usage and control of the devices 1 a-1 n/2 a-2 mlocated in one or more operating theaters. The cloud computing servicescan perform a large number of calculations based on the data gathered bysmart surgical instruments, robots, and other computerized deviceslocated in the operating theater. The hub hardware enables multipledevices or connections to be connected to a computer that communicateswith the cloud computing resources and storage.

Applying cloud computer data processing techniques on the data collectedby the devices 1 a-1 n/2 a-2 m, the surgical data network providesimproved surgical outcomes, reduced costs, and improved patientsatisfaction. At least some of the devices 1 a-1 n/2 a-2 m may beemployed to view tissue states to assess leaks or perfusion of sealedtissue after a tissue sealing and cutting procedure. At least some ofthe devices 1 a-1 n/2 a-2 m may be employed to identify pathology, suchas the effects of diseases, using the cloud-based computing to examinedata including images of samples of body tissue for diagnostic purposes.This includes localization and margin confirmation of tissue andphenotypes. At least some of the devices 1 a-1 n/2 a-2 m may be employedto identify anatomical structures of the body using a variety of sensorsintegrated with imaging devices and techniques such as overlaying imagescaptured by multiple imaging devices. The data gathered by the devices 1a-1 n/2 a-2 m, including image data, may be transferred to the cloud 204or the local computer system 210 or both for data processing andmanipulation including image processing and manipulation. The data maybe analyzed to improve surgical procedure outcomes by determining iffurther treatment, such as the application of endoscopic intervention,emerging technologies, a targeted radiation, targeted intervention, andprecise robotics to tissue-specific sites and conditions, may bepursued. Such data analysis may further employ outcome analyticsprocessing, and using standardized approaches may provide beneficialfeedback to either confirm surgical treatments and the behavior of thesurgeon or suggest modifications to surgical treatments and the behaviorof the surgeon.

In one implementation, the operating theater devices 1 a-1 n may beconnected to the modular communication hub 203 over a wired channel or awireless channel depending on the configuration of the devices 1 a-1 nto a network hub. The network hub 207 may be implemented, in one aspect,as a local network broadcast device that works on the physical layer ofthe Open System Interconnection (OSI) model. The network hub providesconnectivity to the devices 1 a-1 n located in the same operatingtheater network. The network hub 207 collects data in the form ofpackets and sends them to the router in half duplex mode. The networkhub 207 does not store any media access control/Internet Protocol(MAC/IP) to transfer the device data. Only one of the devices 1 a-1 ncan send data at a time through the network hub 207. The network hub 207has no routing tables or intelligence regarding where to sendinformation and broadcasts all network data across each connection andto a remote server 213 (FIG. 9) over the cloud 204. The network hub 207can detect basic network errors such as collisions, but having allinformation broadcast to multiple ports can be a security risk and causebottlenecks.

In another implementation, the operating theater devices 2 a-2 m may beconnected to a network switch 209 over a wired channel or a wirelesschannel. The network switch 209 works in the data link layer of the OSImodel. The network switch 209 is a multicast device for connecting thedevices 2 a-2 m located in the same operating theater to the network.The network switch 209 sends data in the form of frames to the networkrouter 211 and works in full duplex mode. Multiple devices 2 a-2 m cansend data at the same time through the network switch 209. The networkswitch 209 stores and uses MAC addresses of the devices 2 a-2 m totransfer data.

The network hub 207 and/or the network switch 209 are coupled to thenetwork router 211 for connection to the cloud 204. The network router211 works in the network layer of the OSI model. The network router 211creates a route for transmitting data packets received from the networkhub 207 and/or network switch 211 to cloud-based computer resources forfurther processing and manipulation of the data collected by any one ofor all the devices 1 a-1 n/2 a-2 m. The network router 211 may beemployed to connect two or more different networks located in differentlocations, such as, for example, different operating theaters of thesame healthcare facility or different networks located in differentoperating theaters of different healthcare facilities. The networkrouter 211 sends data in the form of packets to the cloud 204 and worksin full duplex mode. Multiple devices can send data at the same time.The network router 211 uses IP addresses to transfer data.

In one example, the network hub 207 may be implemented as a USB hub,which allows multiple USB devices to be connected to a host computer.The USB hub may expand a single USB port into several tiers so thatthere are more ports available to connect devices to the host systemcomputer. The network hub 207 may include wired or wireless capabilitiesto receive information over a wired channel or a wireless channel. Inone aspect, a wireless USB short-range, high-bandwidth wireless radiocommunication protocol may be employed for communication between thedevices 1 a-1 n and devices 2 a-2 m located in the operating theater.

In other examples, the operating theater devices 1 a-1 n/2 a-2 m maycommunicate to the modular communication hub 203 via Bluetooth wirelesstechnology standard for exchanging data over short distances (usingshort-wavelength UHF radio waves in the ISM band from 2.4 to 2.485 GHz)from fixed and mobile devices and building personal area networks(PANs). In other aspects, the operating theater devices 1 a-1 n/2 a-2 mmay communicate to the modular communication hub 203 via a number ofwireless or wired communication standards or protocols, including butnot limited to W-Fi (IEEE 802.11 family), WiMAX (IEEE 802.16 family),IEEE 802.20, long-term evolution (LTE), and Ev-DO, HSPA+, HSDPA+,HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, and Ethernet derivativesthereof, as well as any other wireless and wired protocols that aredesignated as 3G, 4G, 5G, and beyond. The computing module may include aplurality of communication modules. For instance, a first communicationmodule may be dedicated to shorter-range wireless communications such asWi-Fi and Bluetooth, and a second communication module may be dedicatedto longer-range wireless communications such as GPS, EDGE, GPRS, CDMA,WiMAX, LTE, Ev-DO, and others.

The modular communication hub 203 may serve as a central connection forone or all of the operating theater devices 1 a-1 n/2 a-2 m and handlesa data type known as frames. Frames carry the data generated by thedevices 1 a-1 n/2 a-2 m. When a frame is received by the modularcommunication hub 203, it is amplified and transmitted to the networkrouter 211, which transfers the data to the cloud computing resources byusing a number of wireless or wired communication standards orprotocols, as described herein.

The modular communication hub 203 can be used as a standalone device orbe connected to compatible network hubs and network switches to form alarger network. The modular communication hub 203 is generally easy toinstall, configure, and maintain, making it a good option for networkingthe operating theater devices 1 a-1 n/2 a-2 m.

FIG. 9 illustrates a computer-implemented interactive surgical system200. The computer-implemented interactive surgical system 200 is similarin many respects to the computer-implemented interactive surgical system100. For example, the computer-implemented interactive surgical system200 includes one or more surgical systems 202, which are similar in manyrespects to the surgical systems 102. Each surgical system 202 includesat least one surgical hub 206 in communication with a cloud 204 that mayinclude a remote server 213. In one aspect, the computer-implementedinteractive surgical system 200 comprises a modular control tower 236connected to multiple operating theater devices such as, for example,intelligent surgical instruments, robots, and other computerized deviceslocated in the operating theater. As shown in FIG. 10, the modularcontrol tower 236 comprises a modular communication hub 203 coupled to acomputer system 210. As illustrated in the example of FIG. 9, themodular control tower 236 is coupled to an imaging module 238 that iscoupled to an endoscope 239, a generator module 240 that is coupled toan energy device 241, a smoke evacuator module 226, a suction/irrigationmodule 228, a communication module 230, a processor module 232, astorage array 234, a smart device/instrument 235 optionally coupled to adisplay 237, and a non-contact sensor module 242. The operating theaterdevices are coupled to cloud computing resources and data storage viathe modular control tower 236. A robot hub 222 also may be connected tothe modular control tower 236 and to the cloud computing resources. Thedevices/instruments 235, visualization systems 208, among others, may becoupled to the modular control tower 236 via wired or wirelesscommunication standards or protocols, as described herein. The modularcontrol tower 236 may be coupled to a hub display 215 (e.g., monitor,screen) to display and overlay images received from the imaging module,device/instrument display, and/or other visualization systems 208. Thehub display also may display data received from devices connected to themodular control tower in conjunction with images and overlaid images.

FIG. 10 illustrates a surgical hub 206 comprising a plurality of modulescoupled to the modular control tower 236. The modular control tower 236comprises a modular communication hub 203, e.g., a network connectivitydevice, and a computer system 210 to provide local processing,visualization, and imaging, for example. As shown in FIG. 10, themodular communication hub 203 may be connected in a tiered configurationto expand the number of modules (e.g., devices) that may be connected tothe modular communication hub 203 and transfer data associated with themodules to the computer system 210, cloud computing resources, or both.As shown in FIG. 10, each of the network hubs/switches in the modularcommunication hub 203 includes three downstream ports and one upstreamport. The upstream network hub/switch is connected to a processor toprovide a communication connection to the cloud computing resources anda local display 217. Communication to the cloud 204 may be made eitherthrough a wired or a wireless communication channel.

The surgical hub 206 employs a non-contact sensor module 242 to measurethe dimensions of the operating theater and generate a map of thesurgical theater using either ultrasonic or laser-type non-contactmeasurement devices. An ultrasound-based non-contact sensor module scansthe operating theater by transmitting a burst of ultrasound andreceiving the echo when it bounces off the perimeter walls of anoperating theater as described under the heading “Surgical Hub SpatialAwareness Within an Operating Room” in U.S. Provisional PatentApplication Ser. No. 62/611,341, titled INTERACTIVE SURGICAL PLATFORM,filed Dec. 28, 2017, which is herein incorporated by reference in itsentirety, in which the sensor module is configured to determine the sizeof the operating theater and to adjust Bluetooth-pairing distancelimits. A laser-based non-contact sensor module scans the operatingtheater by transmitting laser light pulses, receiving laser light pulsesthat bounce off the perimeter walls of the operating theater, andcomparing the phase of the transmitted pulse to the received pulse todetermine the size of the operating theater and to adjust Bluetoothpairing distance limits, for example.

The computer system 210 comprises a processor 244 and a networkinterface 245. The processor 244 is coupled to a communication module247, storage 248, memory 249, non-volatile memory 250, and input/outputinterface 251 via a system bus. The system bus can be any of severaltypes of bus structure(s) including the memory bus or memory controller,a peripheral bus or external bus, and/or a local bus using any varietyof available bus architectures including, but not limited to, 9-bit bus,Industrial Standard Architecture (ISA), Micro-Charmel Architecture(MSA), Extended ISA (EISA), Intelligent Drive Electronics (IDE), VESALocal Bus (VLB), Peripheral Component Interconnect (PCI), USB, AdvancedGraphics Port (AGP), Personal Computer Memory Card InternationalAssociation bus (PCMCIA), Small Computer Systems Interface (SCSI), orany other proprietary bus.

The processor 244 may be any single-core or multicore processor such asthose known under the trade name ARM Cortex by Texas Instruments. In oneaspect, the processor may be an LM4F230H5QR ARM Cortex-M4F ProcessorCore, available from Texas Instruments, for example, comprising anon-chip memory of 256 KB single-cycle flash memory, or othernon-volatile memory, up to 40 MHz, a prefetch buffer to improveperformance above 40 MHz, a 32 KB single-cycle serial random accessmemory (SRAM), an internal read-only memory (ROM) loaded withStellarisWare® software, a 2 KB electrically erasable programmableread-only memory (EEPROM), and/or one or more pulse width modulation(PWM) modules, one or more quadrature encoder inputs (QEI) analogs, oneor more 12-bit analog-to-digital converters (ADCs) with 12 analog inputchannels, details of which are available for the product datasheet.

In one aspect, the processor 244 may comprise a safety controllercomprising two controller-based families such as TMS570 and RM4x, knownunder the trade name Hercules ARM Cortex R4, also by Texas Instruments.The safety controller may be configured specifically for IEC 61508 andISO 26262 safety critical applications, among others, to provideadvanced integrated safety features while delivering scalableperformance, connectivity, and memory options.

The system memory includes volatile memory and non-volatile memory. Thebasic input/output system (BIOS), containing the basic routines totransfer information between elements within the computer system, suchas during start-up, is stored in non-volatile memory. For example, thenon-volatile memory can include ROM, programmable ROM (PROM),electrically programmable ROM (EPROM), EEPROM, or flash memory. Volatilememory includes random-access memory (RAM), which acts as external cachememory. Moreover, RAM is available in many forms such as SRAM, dynamicRAM (DRAM), synchronous DRAM (SDRAM), double data rate SDRAM (DDRSDRAM), enhanced SDRAM (ESDRAM), Synchlink DRAM (SLDRAM), and directRambus RAM (DRRAM).

The computer system 210 also includes removable/non-removable,volatile/non-volatile computer storage media, such as for example diskstorage. The disk storage includes, but is not limited to, devices likea magnetic disk drive, floppy disk drive, tape drive, Jaz drive, Zipdrive, LS-60 drive, flash memory card, or memory stick. In addition, thedisk storage can include storage media separately or in combination withother storage media including, but not limited to, an optical disc drivesuch as a compact disc ROM device (CD-ROM), compact disc recordabledrive (CD-R Drive), compact disc rewritable drive (CD-RW Drive), or adigital versatile disc ROM drive (DVD-ROM). To facilitate the connectionof the disk storage devices to the system bus, a removable ornon-removable interface may be employed.

It is to be appreciated that the computer system 210 includes softwarethat acts as an intermediary between users and the basic computerresources described in a suitable operating environment. Such softwareincludes an operating system. The operating system, which can be storedon the disk storage, acts to control and allocate resources of thecomputer system. System applications take advantage of the management ofresources by the operating system through program modules and programdata stored either in the system memory or on the disk storage. It is tobe appreciated that various components described herein can beimplemented with various operating systems or combinations of operatingsystems.

A user enters commands or information into the computer system 210through input device(s) coupled to the I/O interface 251. The inputdevices include, but are not limited to, a pointing device such as amouse, trackball, stylus, touch pad, keyboard, microphone, joystick,game pad, satellite dish, scanner, TV tuner card, digital camera,digital video camera, web camera, and the like. These and other inputdevices connect to the processor through the system bus via interfaceport(s). The interface port(s) include, for example, a serial port, aparallel port, a game port, and a USB. The output device(s) use some ofthe same types of ports as input device(s). Thus, for example, a USBport may be used to provide input to the computer system and to outputinformation from the computer system to an output device. An outputadapter is provided to illustrate that there are some output deviceslike monitors, displays, speakers, and printers, among other outputdevices that require special adapters. The output adapters include, byway of illustration and not limitation, video and sound cards thatprovide a means of connection between the output device and the systembus. It should be noted that other devices and/or systems of devices,such as remote computer(s), provide both input and output capabilities.

The computer system 210 can operate in a networked environment usinglogical connections to one or more remote computers, such as cloudcomputer(s), or local computers. The remote cloud computer(s) can be apersonal computer, server, router, network PC, workstation,microprocessor-based appliance, peer device, or other common networknode, and the like, and typically includes many or all of the elementsdescribed relative to the computer system. For purposes of brevity, onlya memory storage device is illustrated with the remote computer(s). Theremote computer(s) is logically connected to the computer system througha network interface and then physically connected via a communicationconnection. The network interface encompasses communication networkssuch as local area networks (LANs) and wide area networks (WANs). LANtechnologies include Fiber Distributed Data Interface (FDDI), CopperDistributed Data Interface (CDDI), Ethernet/IEEE 802.3, Token Ring/IEEE802.5 and the like. WAN technologies include, but are not limited to,point-to-point links, circuit-switching networks like IntegratedServices Digital Networks (ISDN) and variations thereon,packet-switching networks, and Digital Subscriber Lines (DSL).

In various aspects, the computer system 210 of FIG. 10, the imagingmodule 238 and/or visualization system 208, and/or the processor module232 of FIGS. 9-10, may comprise an image processor, image-processingengine, media processor, or any specialized digital signal processor(DSP) used for the processing of digital images. The image processor mayemploy parallel computing with single instruction, multiple data (SIMD)or multiple instruction, multiple data (MIMD) technologies to increasespeed and efficiency. The digital image-processing engine can perform arange of tasks. The image processor may be a system on a chip withmulticore processor architecture.

The communication connection(s) refers to the hardware/software employedto connect the network interface to the bus. While the communicationconnection is shown for illustrative clarity inside the computer system,it can also be external to the computer system 210. Thehardware/software necessary for connection to the network interfaceincludes, for illustrative purposes only, internal and externaltechnologies such as modems, including regular telephone-grade modems,cable modems, and DSL modems, ISDN adapters, and Ethernet cards.

FIG. 11 illustrates a functional block diagram of one aspect of a USBnetwork hub 300 device, in accordance with at least one aspect of thepresent disclosure. In the illustrated aspect, the USB network hubdevice 300 employs a TUSB2036 integrated circuit hub by TexasInstruments. The USB network hub 300 is a CMOS device that provides anupstream USB transceiver port 302 and up to three downstream USBtransceiver ports 304, 306, 308 in compliance with the USB 2.0specification. The upstream USB transceiver port 302 is a differentialroot data port comprising a differential data minus (DM0) input pairedwith a differential data plus (DP0) input. The three downstream USBtransceiver ports 304, 306, 308 are differential data ports where eachport includes differential data plus (DP1-DP3) outputs paired withdifferential data minus (DM1-DM3) outputs.

The USB network hub 300 device is implemented with a digital statemachine instead of a microcontroller, and no firmware programming isrequired. Fully compliant USB transceivers are integrated into thecircuit for the upstream USB transceiver port 302 and all downstream USBtransceiver ports 304, 306, 308. The downstream USB transceiver ports304, 306, 308 support both full-speed and low-speed devices byautomatically setting the slew rate according to the speed of the deviceattached to the ports. The USB network hub 300 device may be configuredeither in bus-powered or self-powered mode and includes a hub powerlogic 312 to manage power.

The USB network hub 300 device includes a serial interface engine 310(SIE). The SIE 310 is the front end of the USB network hub 300 hardwareand handles most of the protocol described in chapter 8 of the USBspecification. The SIE 310 typically comprehends signaling up to thetransaction level. The functions that it handles could include: packetrecognition, transaction sequencing, SOP, EOP, RESET, and RESUME signaldetection/generation, clock/data separation, non-return-to-zero invert(NRZI) data encoding/decoding and bit-stuffing, CRC generation andchecking (token and data), packet ID (PID) generation andchecking/decoding, and/or serial-parallel/parallel-serial conversion.The 310 receives a clock input 314 and is coupled to a suspend/resumelogic and frame timer 316 circuit and a hub repeater circuit 318 tocontrol communication between the upstream USB transceiver port 302 andthe downstream USB transceiver ports 304, 306, 308 through port logiccircuits 320, 322, 324. The SIE 310 is coupled to a command decoder 326via interface logic 328 to control commands from a serial EEPROM via aserial EEPROM interface 330.

In various aspects, the USB network hub 300 can connect 127 functionsconfigured in up to six logical layers (tiers) to a single computer.Further, the USB network hub 300 can connect to all peripherals using astandardized four-wire cable that provides both communication and powerdistribution. The power configurations are bus-powered and self-poweredmodes. The USB network hub 300 may be configured to support four modesof power management: a bus-powered hub, with either individual-portpower management or ganged-port power management, and the self-poweredhub, with either individual-port power management or ganged-port powermanagement. In one aspect, using a USB cable, the USB network hub 300,the upstream USB transceiver port 302 is plugged into a USB hostcontroller, and the downstream USB transceiver ports 304, 306, 308 areexposed for connecting USB compatible devices, and so forth.

Additional details regarding the structure and function of the surgicalhub and/or surgical hub networks can be found in U.S. Provisional PatentApplication No. 62/659,900, titled METHOD OF HUB COMMUNICATION, filedApr. 19, 2018, which is hereby incorporated by reference herein in itsentirety.

Cloud System Hardware and Functional Modules

FIG. 12 is a block diagram of the computer-implemented interactivesurgical system, in accordance with at least one aspect of the presentdisclosure. In one aspect, the computer-implemented interactive surgicalsystem is configured to monitor and analyze data related to theoperation of various surgical systems that include surgical hubs,surgical instruments, robotic devices and operating theaters orhealthcare facilities. The computer-implemented interactive surgicalsystem comprises a cloud-based analytics system. Although thecloud-based analytics system is described as a surgical system, it isnot necessarily limited as such and could be a cloud-based medicalsystem generally. As illustrated in FIG. 12, the cloud-based analyticssystem comprises a plurality of surgical instruments 7012 (may be thesame or similar to instruments 112), a plurality of surgical hubs 7006(may be the same or similar to hubs 106), and a surgical data network7001 (may be the same or similar to network 201) to couple the surgicalhubs 7006 to the cloud 7004 (may be the same or similar to cloud 204).Each of the plurality of surgical hubs 7006 is communicatively coupledto one or more surgical instruments 7012. The hubs 7006 are alsocommunicatively coupled to the cloud 7004 of the computer-implementedinteractive surgical system via the network 7001. The cloud 7004 is aremote centralized source of hardware and software for storing,manipulating, and communicating data generated based on the operation ofvarious surgical systems. As shown in FIG. 12, access to the cloud 7004is achieved via the network 7001, which may be the Internet or someother suitable computer network. Surgical hubs 7006 that are coupled tothe cloud 7004 can be considered the client side of the cloud computingsystem (i.e., cloud-based analytics system). Surgical instruments 7012are paired with the surgical hubs 7006 for control and implementation ofvarious surgical procedures or operations as described herein.

In addition, surgical instruments 7012 may comprise transceivers fordata transmission to and from their corresponding surgical hubs 7006(which may also comprise transceivers). Combinations of surgicalinstruments 7012 and corresponding hubs 7006 may indicate particularlocations, such as operating theaters in healthcare facilities (e.g.,hospitals), for providing medical operations. For example, the memory ofa surgical hub 7006 may store location data. As shown in FIG. 12, thecloud 7004 comprises central servers 7013 (which may be same or similarto remote server 113 in FIG. 1 and/or remote server 213 in FIG. 9), hubapplication servers 7002, data analytics modules 7034, and aninput/output (“I/O”) interface 7007. The central servers 7013 of thecloud 7004 collectively administer the cloud computing system, whichincludes monitoring requests by client surgical hubs 7006 and managingthe processing capacity of the cloud 7004 for executing the requests.Each of the central servers 7013 comprises one or more processors 7008coupled to suitable memory devices 7010 which can include volatilememory such as random-access memory (RAM) and non-volatile memory suchas magnetic storage devices. The memory devices 7010 may comprisemachine executable instructions that when executed cause the processors7008 to execute the data analytics modules 7034 for the cloud-based dataanalysis, operations, recommendations and other operations describedbelow. Moreover, the processors 7008 can execute the data analyticsmodules 7034 independently or in conjunction with hub applicationsindependently executed by the hubs 7006. The central servers 7013 alsocomprise aggregated medical data databases 2212, which can reside in thememory 2210.

Based on connections to various surgical hubs 7006 via the network 7001,the cloud 7004 can aggregate data from specific data generated byvarious surgical instruments 7012 and their corresponding hubs 7006.Such aggregated data may be stored within the aggregated medicaldatabases 7011 of the cloud 7004. In particular, the cloud 7004 mayadvantageously perform data analysis and operations on the aggregateddata to yield insights and/or perform functions that individual hubs7006 could not achieve on their own. To this end, as shown in FIG. 12,the cloud 7004 and the surgical hubs 7006 are communicatively coupled totransmit and receive information. The I/O interface 7007 is connected tothe plurality of surgical hubs 7006 via the network 7001. In this way,the I/O interface 7007 can be configured to transfer information betweenthe surgical hubs 7006 and the aggregated medical data databases 7011.Accordingly, the I/O interface 7007 may facilitate read/write operationsof the cloud-based analytics system. Such read/write operations may beexecuted in response to requests from hubs 7006. These requests could betransmitted to the hubs 7006 through the hub applications. The I/Ointerface 7007 may include one or more high speed data ports, which mayinclude universal serial bus (USB) ports, IEEE 1394 ports, as well asW-Fi and Bluetooth I/O interfaces for connecting the cloud 7004 to hubs7006. The hub application servers 7002 of the cloud 7004 are configuredto host and supply shared capabilities to software applications (e.g.hub applications) executed by surgical hubs 7006. For example, the hubapplication servers 7002 may manage requests made by the hubapplications through the hubs 7006, control access to the aggregatedmedical data databases 7011, and perform load balancing. The dataanalytics modules 7034 are described in further detail with reference toFIG. 13.

The particular cloud computing system configuration described in thepresent disclosure is specifically designed to address various issuesarising in the context of medical operations and procedures performedusing medical devices, such as the surgical instruments 7012, 112. Inparticular, the surgical instruments 7012 may be digital surgicaldevices configured to interact with the cloud 7004 for implementingtechniques to improve the performance of surgical operations. Varioussurgical instruments 7012 and/or surgical hubs 7006 may comprise touchcontrolled user interfaces such that clinicians may control aspects ofinteraction between the surgical instruments 7012 and the cloud 7004.Other suitable user interfaces for control such as auditory controlleduser interfaces can also be used.

FIG. 13 is a block diagram which illustrates the functional architectureof the computer-implemented interactive surgical system, in accordancewith at least one aspect of the present disclosure. The cloud-basedanalytics system includes a plurality of data analytics modules 7034that may be executed by the processors 7008 of the cloud 7004 forproviding data analytic solutions to problems specifically arising inthe medical field. As shown in FIG. 13, the functions of the cloud-baseddata analytics modules 7034 may be assisted via hub applications 7014hosted by the hub application servers 7002 that may be accessed onsurgical hubs 7006. The cloud processors 7008 and hub applications 7014may operate in conjunction to execute the data analytics modules 7034.Application program interfaces (APIs) 7016 define the set of protocolsand routines corresponding to the hub applications 7014. Additionally,the APIs 7016 manage the storing and retrieval of data into and from theaggregated medical data databases 7011 for the operations of theapplications 7014. The caches 7018 also store data (e.g., temporarily)and are coupled to the APIs 7016 for more efficient retrieval of dataused by the applications 7014. The data analytics modules 7034 in FIG.13 include modules for resource optimization 7020, data collection andaggregation 7022, authorization and security 7024, control programupdating 7026, patient outcome analysis 7028, recommendations 7030, anddata sorting and prioritization 7032. Other suitable data analyticsmodules could also be implemented by the cloud 7004, according to someaspects. In one aspect, the data analytics modules are used for specificrecommendations based on analyzing trends, outcomes, and other data.

For example, the data collection and aggregation module 7022 could beused to generate self-describing data (e.g., metadata) includingidentification of notable features or configuration (e.g., trends),management of redundant data sets, and storage of the data in paireddata sets which can be grouped by surgery but not necessarily keyed toactual surgical dates and surgeons. In particular, pair data setsgenerated from operations of surgical instruments 7012 can compriseapplying a binary classification, e.g., a bleeding or a non-bleedingevent. More generally, the binary classification may be characterized aseither a desirable event (e.g., a successful surgical procedure) or anundesirable event (e.g., a misfired or misused surgical instrument7012). The aggregated self-describing data may correspond to individualdata received from various groups or subgroups of surgical hubs 7006.Accordingly, the data collection and aggregation module 7022 cangenerate aggregated metadata or other organized data based on raw datareceived from the surgical hubs 7006. To this end, the processors 7008can be operationally coupled to the hub applications 7014 and aggregatedmedical data databases 7011 for executing the data analytics modules7034. The data collection and aggregation module 7022 may store theaggregated organized data into the aggregated medical data databases2212.

The resource optimization module 7020 can be configured to analyze thisaggregated data to determine an optimal usage of resources for aparticular or group of healthcare facilities. For example, the resourceoptimization module 7020 may determine an optimal order point ofsurgical stapling instruments 7012 for a group of healthcare facilitiesbased on corresponding predicted demand of such instruments 7012. Theresource optimization module 7020 might also assess the resource usageor other operational configurations of various healthcare facilities todetermine whether resource usage could be improved. Similarly, therecommendations module 7030 can be configured to analyze aggregatedorganized data from the data collection and aggregation module 7022 toprovide recommendations. For example, the recommendations module 7030could recommend to healthcare facilities (e.g., medical serviceproviders such as hospitals) that a particular surgical instrument 7012should be upgraded to an improved version based on a higher thanexpected error rate, for example. Additionally, the recommendationsmodule 7030 and/or resource optimization module 7020 could recommendbetter supply chain parameters such as product reorder points andprovide suggestions of different surgical instrument 7012, uses thereof,or procedure steps to improve surgical outcomes. The healthcarefacilities can receive such recommendations via corresponding surgicalhubs 7006. More specific recommendations regarding parameters orconfigurations of various surgical instruments 7012 can also beprovided. Hubs 7006 and/or surgical instruments 7012 each could alsohave display screens that display data or recommendations provided bythe cloud 7004.

The patient outcome analysis module 7028 can analyze surgical outcomesassociated with currently used operational parameters of surgicalinstruments 7012. The patient outcome analysis module 7028 may alsoanalyze and assess other potential operational parameters. In thisconnection, the recommendations module 7030 could recommend using theseother potential operational parameters based on yielding better surgicaloutcomes, such as better sealing or less bleeding. For example, therecommendations module 7030 could transmit recommendations to a surgicalhub 7006 regarding when to use a particular cartridge for acorresponding stapling surgical instrument 7012. Thus, the cloud-basedanalytics system, while controlling for common variables, may beconfigured to analyze the large collection of raw data and to providecentralized recommendations over multiple healthcare facilities(advantageously determined based on aggregated data). For example, thecloud-based analytics system could analyze, evaluate, and/or aggregatedata based on type of medical practice, type of patient, number ofpatients, geographic similarity between medical providers, which medicalproviders/facilities use similar types of instruments, etc., in a waythat no single healthcare facility alone would be able to analyzeindependently.

The control program updating module 7026 could be configured toimplement various surgical instrument 7012 recommendations whencorresponding control programs are updated. For example, the patientoutcome analysis module 7028 could identify correlations linkingspecific control parameters with successful (or unsuccessful) results.Such correlations may be addressed when updated control programs aretransmitted to surgical instruments 7012 via the control programupdating module 7026. Updates to instruments 7012 that are transmittedvia a corresponding hub 7006 may incorporate aggregated performance datathat was gathered and analyzed by the data collection and aggregationmodule 7022 of the cloud 7004. Additionally, the patient outcomeanalysis module 7028 and recommendations module 7030 could identifyimproved methods of using instruments 7012 based on aggregatedperformance data.

The cloud-based analytics system may include security featuresimplemented by the cloud 7004. These security features may be managed bythe authorization and security module 7024. Each surgical hub 7006 canhave associated unique credentials such as username, password, and othersuitable security credentials. These credentials could be stored in thememory 7010 and be associated with a permitted cloud access level. Forexample, based on providing accurate credentials, a surgical hub 7006may be granted access to communicate with the cloud to a predeterminedextent (e.g., may only engage in transmitting or receiving certaindefined types of information). To this end, the aggregated medical datadatabases 7011 of the cloud 7004 may comprise a database of authorizedcredentials for verifying the accuracy of provided credentials.Different credentials may be associated with varying levels ofpermission for interaction with the cloud 7004, such as a predeterminedaccess level for receiving the data analytics generated by the cloud7004.

Furthermore, for security purposes, the cloud could maintain a databaseof hubs 7006, instruments 7012, and other devices that may comprise a“black list” of prohibited devices. In particular, a surgical hub 7006listed on the black list may not be permitted to interact with thecloud, while surgical instruments 7012 listed on the black list may nothave functional access to a corresponding hub 7006 and/or may beprevented from fully functioning when paired to its corresponding hub7006. Additionally or alternatively, the cloud 7004 may flag instruments7012 based on incompatibility or other specified criteria. In thismanner, counterfeit medical devices and improper reuse of such devicesthroughout the cloud-based analytics system can be identified andaddressed.

The surgical instruments 7012 may use wireless transceivers to transmitwireless signals that may represent, for example, authorizationcredentials for access to corresponding hubs 7006 and the cloud 7004.Wired transceivers may also be used to transmit signals. Suchauthorization credentials can be stored in the respective memory devicesof the surgical instruments 7012. The authorization and security module7024 can determine whether the authorization credentials are accurate orcounterfeit. The authorization and security module 7024 may alsodynamically generate authorization credentials for enhanced security.The credentials could also be encrypted, such as by using hash basedencryption. Upon transmitting proper authorization, the surgicalinstruments 7012 may transmit a signal to the corresponding hubs 7006and ultimately the cloud 7004 to indicate that the instruments 7012 areready to obtain and transmit medical data. In response, the cloud 7004may transition into a state enabled for receiving medical data forstorage into the aggregated medical data databases 7011. This datatransmission readiness could be indicated by a light indicator on theinstruments 7012, for example. The cloud 7004 can also transmit signalsto surgical instruments 7012 for updating their associated controlprograms. The cloud 7004 can transmit signals that are directed to aparticular class of surgical instruments 7012 (e.g., electrosurgicalinstruments) so that software updates to control programs are onlytransmitted to the appropriate surgical instruments 7012. Moreover, thecloud 7004 could be used to implement system wide solutions to addresslocal or global problems based on selective data transmission andauthorization credentials. For example, if a group of surgicalinstruments 7012 are identified as having a common manufacturing defect,the cloud 7004 may change the authorization credentials corresponding tothis group to implement an operational lockout of the group.

The cloud-based analytics system may allow for monitoring multiplehealthcare facilities (e.g., medical facilities like hospitals) todetermine improved practices and recommend changes (via therecommendations module 2030, for example) accordingly. Thus, theprocessors 7008 of the cloud 7004 can analyze data associated with anindividual healthcare facility to identify the facility and aggregatethe data with other data associated with other healthcare facilities ina group. Groups could be defined based on similar operating practices orgeographical location, for example. In this way, the cloud 7004 mayprovide healthcare facility group wide analysis and recommendations. Thecloud-based analytics system could also be used for enhanced situationalawareness. For example, the processors 7008 may predictively model theeffects of recommendations on the cost and effectiveness for aparticular facility (relative to overall operations and/or variousmedical procedures). The cost and effectiveness associated with thatparticular facility can also be compared to a corresponding local regionof other facilities or any other comparable facilities.

The data sorting and prioritization module 7032 may prioritize and sortdata based on criticality (e.g., the severity of a medical eventassociated with the data, unexpectedness, suspiciousness). This sortingand prioritization may be used in conjunction with the functions of theother data analytics modules 7034 described above to improve thecloud-based analytics and operations described herein. For example, thedata sorting and prioritization module 7032 can assign a priority to thedata analysis performed by the data collection and aggregation module7022 and patient outcome analysis modules 7028. Different prioritizationlevels can result in particular responses from the cloud 7004(corresponding to a level of urgency) such as escalation for anexpedited response, special processing, exclusion from the aggregatedmedical data databases 7011, or other suitable responses. Moreover, ifnecessary, the cloud 7004 can transmit a request (e.g. a push message)through the hub application servers for additional data fromcorresponding surgical instruments 7012. The push message can result ina notification displayed on the corresponding hubs 7006 for requestingsupporting or additional data. This push message may be required insituations in which the cloud detects a significant irregularity oroutlier and the cloud cannot determine the cause of the irregularity.The central servers 7013 may be programmed to trigger this push messagein certain significant circumstances, such as when data is determined tobe different from an expected value beyond a predetermined threshold orwhen it appears security has been comprised, for example.

Additional details regarding the cloud analysis system can be found inU.S. Provisional Patent Application No. 62/659,900, titled METHOD OF HUBCOMMUNICATION, filed Apr. 19, 2018, which is hereby incorporated byreference herein in its entirety.

Situational Awareness

Although an “intelligent” device including control algorithms thatrespond to sensed data can be an improvement over a “dumb” device thatoperates without accounting for sensed data, some sensed data can beincomplete or inconclusive when considered in isolation, i.e., withoutthe context of the type of surgical procedure being performed or thetype of tissue that is being operated on. Without knowing the proceduralcontext (e.g., knowing the type of tissue being operated on or the typeof procedure being performed), the control algorithm may control themodular device incorrectly or suboptimally given the particularcontext-free sensed data. For example, the optimal manner for a controlalgorithm to control a surgical instrument in response to a particularsensed parameter can vary according to the particular tissue type beingoperated on. This is due to the fact that different tissue types havedifferent properties (e.g., resistance to tearing) and thus responddifferently to actions taken by surgical instruments. Therefore, it maybe desirable for a surgical instrument to take different actions evenwhen the same measurement for a particular parameter is sensed. As onespecific example, the optimal manner in which to control a surgicalstapling and cutting instrument in response to the instrument sensing anunexpectedly high force to close its end effector will vary dependingupon whether the tissue type is susceptible or resistant to tearing. Fortissues that are susceptible to tearing, such as lung tissue, theinstrument's control algorithm would optimally ramp down the motor inresponse to an unexpectedly high force to close to avoid tearing thetissue. For tissues that are resistant to tearing, such as stomachtissue, the instrument's control algorithm would optimally ramp up themotor in response to an unexpectedly high force to close to ensure thatthe end effector is clamped properly on the tissue. Without knowingwhether lung or stomach tissue has been clamped, the control algorithmmay make a suboptimal decision.

One solution utilizes a surgical hub including a system that isconfigured to derive information about the surgical procedure beingperformed based on data received from various data sources and thencontrol the paired modular devices accordingly. In other words, thesurgical hub is configured to infer information about the surgicalprocedure from received data and then control the modular devices pairedto the surgical hub based upon the inferred context of the surgicalprocedure. FIG. 14 illustrates a diagram of a situationally awaresurgical system 5100, in accordance with at least one aspect of thepresent disclosure. In some exemplifications, the data sources 5126include, for example, the modular devices 5102 (which can includesensors configured to detect parameters associated with the patientand/or the modular device itself), databases 5122 (e.g., an EMR databasecontaining patient records), and patient monitoring devices 5124 (e.g.,a blood pressure (BP) monitor and an electrocardiography (EKG) monitor).

A surgical hub 5104, which may be similar to the hub 106 in manyrespects, can be configured to derive the contextual informationpertaining to the surgical procedure from the data based upon, forexample, the particular combination(s) of received data or theparticular order in which the data is received from the data sources5126. The contextual information inferred from the received data caninclude, for example, the type of surgical procedure being performed,the particular step of the surgical procedure that the surgeon isperforming, the type of tissue being operated on, or the body cavitythat is the subject of the procedure. This ability by some aspects ofthe surgical hub 5104 to derive or infer information related to thesurgical procedure from received data can be referred to as “situationalawareness.” In one exemplification, the surgical hub 5104 canincorporate a situational awareness system, which is the hardware and/orprogramming associated with the surgical hub 5104 that derivescontextual information pertaining to the surgical procedure from thereceived data.

The situational awareness system of the surgical hub 5104 can beconfigured to derive the contextual information from the data receivedfrom the data sources 5126 in a variety of different ways. In oneexemplification, the situational awareness system includes a patternrecognition system, or machine learning system (e.g., an artificialneural network), that has been trained on training data to correlatevarious inputs (e.g., data from databases 5122, patient monitoringdevices 5124, and/or modular devices 5102) to corresponding contextualinformation regarding a surgical procedure. In other words, a machinelearning system can be trained to accurately derive contextualinformation regarding a surgical procedure from the provided inputs. Inanother exemplification, the situational awareness system can include alookup table storing pre-characterized contextual information regardinga surgical procedure in association with one or more inputs (or rangesof inputs) corresponding to the contextual information. In response to aquery with one or more inputs, the lookup table can return thecorresponding contextual information for the situational awarenesssystem for controlling the modular devices 5102. In one exemplification,the contextual information received by the situational awareness systemof the surgical hub 5104 is associated with a particular controladjustment or set of control adjustments for one or more modular devices5102. In another exemplification, the situational awareness systemincludes a further machine learning system, lookup table, or other suchsystem, which generates or retrieves one or more control adjustments forone or more modular devices 5102 when provided the contextualinformation as input.

A surgical hub 5104 incorporating a situational awareness systemprovides a number of benefits for the surgical system 5100. One benefitincludes improving the interpretation of sensed and collected data,which would in turn improve the processing accuracy and/or the usage ofthe data during the course of a surgical procedure. To return to aprevious example, a situationally aware surgical hub 5104 coulddetermine what type of tissue was being operated on; therefore, when anunexpectedly high force to close the surgical instrument's end effectoris detected, the situationally aware surgical hub 5104 could correctlyramp up or ramp down the motor of the surgical instrument for the typeof tissue.

As another example, the type of tissue being operated can affect theadjustments that are made to the compression rate and load thresholds ofa surgical stapling and cutting instrument for a particular tissue gapmeasurement. A situationally aware surgical hub 5104 could infer whethera surgical procedure being performed is a thoracic or an abdominalprocedure, allowing the surgical hub 5104 to determine whether thetissue clamped by an end effector of the surgical stapling and cuttinginstrument is lung (for a thoracic procedure) or stomach (for anabdominal procedure) tissue. The surgical hub 5104 could then adjust thecompression rate and load thresholds of the surgical stapling andcutting instrument appropriately for the type of tissue.

As yet another example, the type of body cavity being operated in duringan insufflation procedure can affect the function of a smoke evacuator.A situationally aware surgical hub 5104 could determine whether thesurgical site is under pressure (by determining that the surgicalprocedure is utilizing insufflation) and determine the procedure type.As a procedure type is generally performed in a specific body cavity,the surgical hub 5104 could then control the motor rate of the smokeevacuator appropriately for the body cavity being operated in. Thus, asituationally aware surgical hub 5104 could provide a consistent amountof smoke evacuation for both thoracic and abdominal procedures.

As yet another example, the type of procedure being performed can affectthe optimal energy level for an ultrasonic surgical instrument or radiofrequency (RF) electrosurgical instrument to operate at. Arthroscopicprocedures, for example, require higher energy levels because the endeffector of the ultrasonic surgical instrument or RF electrosurgicalinstrument is immersed in fluid. A situationally aware surgical hub 5104could determine whether the surgical procedure is an arthroscopicprocedure. The surgical hub 5104 could then adjust the RF power level orthe ultrasonic amplitude of the generator (i.e., “energy level”) tocompensate for the fluid filled environment. Relatedly, the type oftissue being operated on can affect the optimal energy level for anultrasonic surgical instrument or RF electrosurgical instrument tooperate at. A situationally aware surgical hub 5104 could determine whattype of surgical procedure is being performed and then customize theenergy level for the ultrasonic surgical instrument or RFelectrosurgical instrument, respectively, according to the expectedtissue profile for the surgical procedure. Furthermore, a situationallyaware surgical hub 5104 can be configured to adjust the energy level forthe ultrasonic surgical instrument or RF electrosurgical instrumentthroughout the course of a surgical procedure, rather than just on aprocedure-by-procedure basis. A situationally aware surgical hub 5104could determine what step of the surgical procedure is being performedor will subsequently be performed and then update the control algorithmsfor the generator and/or ultrasonic surgical instrument or RFelectrosurgical instrument to set the energy level at a valueappropriate for the expected tissue type according to the surgicalprocedure step.

As yet another example, data can be drawn from additional data sources5126 to improve the conclusions that the surgical hub 5104 draws fromone data source 5126. A situationally aware surgical hub 5104 couldaugment data that it receives from the modular devices 5102 withcontextual information that it has built up regarding the surgicalprocedure from other data sources 5126. For example, a situationallyaware surgical hub 5104 can be configured to determine whetherhemostasis has occurred (i.e., whether bleeding at a surgical site hasstopped) according to video or image data received from a medicalimaging device. However, in some cases the video or image data can beinconclusive. Therefore, in one exemplification, the surgical hub 5104can be further configured to compare a physiologic measurement (e.g.,blood pressure sensed by a BP monitor communicably connected to thesurgical hub 5104) with the visual or image data of hemostasis (e.g.,from a medical imaging device 124 (FIG. 2) communicably coupled to thesurgical hub 5104) to make a determination on the integrity of thestaple line or tissue weld. In other words, the situational awarenesssystem of the surgical hub 5104 can consider the physiologicalmeasurement data to provide additional context in analyzing thevisualization data. The additional context can be useful when thevisualization data may be inconclusive or incomplete on its own.

Another benefit includes proactively and automatically controlling thepaired modular devices 5102 according to the particular step of thesurgical procedure that is being performed to reduce the number of timesthat medical personnel are required to interact with or control thesurgical system 5100 during the course of a surgical procedure. Forexample, a situationally aware surgical hub 5104 could proactivelyactivate the generator to which an RF electrosurgical instrument isconnected if it determines that a subsequent step of the procedurerequires the use of the instrument. Proactively activating the energysource allows the instrument to be ready for use a soon as the precedingstep of the procedure is completed.

As another example, a situationally aware surgical hub 5104 coulddetermine whether the current or subsequent step of the surgicalprocedure requires a different view or degree of magnification on thedisplay according to the feature(s) at the surgical site that thesurgeon is expected to need to view. The surgical hub 5104 could thenproactively change the displayed view (supplied by, e.g., a medicalimaging device for the visualization system 108) accordingly so that thedisplay automatically adjusts throughout the surgical procedure.

As yet another example, a situationally aware surgical hub 5104 coulddetermine which step of the surgical procedure is being performed orwill subsequently be performed and whether particular data orcomparisons between data will be required for that step of the surgicalprocedure. The surgical hub 5104 can be configured to automatically callup data screens based upon the step of the surgical procedure beingperformed, without waiting for the surgeon to ask for the particularinformation.

Another benefit includes checking for errors during the setup of thesurgical procedure or during the course of the surgical procedure. Forexample, a situationally aware surgical hub 5104 could determine whetherthe operating theater is setup properly or optimally for the surgicalprocedure to be performed. The surgical hub 5104 can be configured todetermine the type of surgical procedure being performed, retrieve thecorresponding checklists, product location, or setup needs (e.g., from amemory), and then compare the current operating theater layout to thestandard layout for the type of surgical procedure that the surgical hub5104 determines is being performed. In one exemplification, the surgicalhub 5104 can be configured to compare the list of items for theprocedure scanned by a suitable scanner for example, and/or a list ofdevices paired with the surgical hub 5104 to a recommended oranticipated manifest of items and/or devices for the given surgicalprocedure. If there are any discontinuities between the lists, thesurgical hub 5104 can be configured to provide an alert indicating thata particular modular device 5102, patient monitoring device 5124, and/orother surgical item is missing. In one exemplification, the surgical hub5104 can be configured to determine the relative distance or position ofthe modular devices 5102 and patient monitoring devices 5124 viaproximity sensors, for example. The surgical hub 5104 can compare therelative positions of the devices to a recommended or anticipated layoutfor the particular surgical procedure. If there are any discontinuitiesbetween the layouts, the surgical hub 5104 can be configured to providean alert indicating that the current layout for the surgical proceduredeviates from the recommended layout.

As another example, a situationally aware surgical hub 5104 coulddetermine whether the surgeon (or other medical personnel) was making anerror or otherwise deviating from the expected course of action duringthe course of a surgical procedure. For example, the surgical hub 5104can be configured to determine the type of surgical procedure beingperformed, retrieve the corresponding list of steps or order ofequipment usage (e.g., from a memory), and then compare the steps beingperformed or the equipment being used during the course of the surgicalprocedure to the expected steps or equipment for the type of surgicalprocedure that the surgical hub 5104 determined is being performed. Inone exemplification, the surgical hub 5104 can be configured to providean alert indicating that an unexpected action is being performed or anunexpected device is being utilized at the particular step in thesurgical procedure.

Overall, the situational awareness system for the surgical hub 5104improves surgical procedure outcomes by adjusting the surgicalinstruments (and other modular devices 5102) for the particular contextof each surgical procedure (such as adjusting to different tissue types)and validating actions during a surgical procedure. The situationalawareness system also improves surgeons' efficiency in performingsurgical procedures by automatically suggesting next steps, providingdata, and adjusting displays and other modular devices 5102 in thesurgical theater according to the specific context of the procedure.

Referring now to FIG. 15, a timeline 5200 depicting situationalawareness of a hub, such as the surgical hub 106 or 206 (FIGS. 1-11),for example, is depicted. The timeline 5200 is an illustrative surgicalprocedure and the contextual information that the surgical hub 106, 206can derive from the data received from the data sources at each step inthe surgical procedure. The timeline 5200 depicts the typical steps thatwould be taken by the nurses, surgeons, and other medical personnelduring the course of a lung segmentectomy procedure, beginning withsetting up the operating theater and ending with transferring thepatient to a post-operative recovery room.

The situationally aware surgical hub 106, 206 receives data from thedata sources throughout the course of the surgical procedure, includingdata generated each time medical personnel utilize a modular device thatis paired with the surgical hub 106, 206. The surgical hub 106, 206 canreceive this data from the paired modular devices and other data sourcesand continually derive inferences (i.e., contextual information) aboutthe ongoing procedure as new data is received, such as which step of theprocedure is being performed at any given time. The situationalawareness system of the surgical hub 106, 206 is able to, for example,record data pertaining to the procedure for generating reports, verifythe steps being taken by the medical personnel, provide data or prompts(e.g., via a display screen) that may be pertinent for the particularprocedural step, adjust modular devices based on the context (e.g.,activate monitors, adjust the field of view (FOV) of the medical imagingdevice, or change the energy level of an ultrasonic surgical instrumentor RF electrosurgical instrument), and take any other such actiondescribed above.

As the first step 5202 in this illustrative procedure, the hospitalstaff members retrieve the patient's EMR from the hospital's EMRdatabase. Based on select patient data in the EMR, the surgical hub 106,206 determines that the procedure to be performed is a thoracicprocedure.

Second step 5204, the staff members scan the incoming medical suppliesfor the procedure. The surgical hub 106, 206 cross-references thescanned supplies with a list of supplies that are utilized in varioustypes of procedures and confirms that the mix of supplies corresponds toa thoracic procedure. Further, the surgical hub 106, 206 is also able todetermine that the procedure is not a wedge procedure (because theincoming supplies either lack certain supplies that are necessary for athoracic wedge procedure or do not otherwise correspond to a thoracicwedge procedure).

Third step 5206, the medical personnel scan the patient band via ascanner that is communicably connected to the surgical hub 106, 206. Thesurgical hub 106, 206 can then confirm the patient's identity based onthe scanned data.

Fourth step 5208, the medical staff turns on the auxiliary equipment.The auxiliary equipment being utilized can vary according to the type ofsurgical procedure and the techniques to be used by the surgeon, but inthis illustrative case they include a smoke evacuator, insufflator, andmedical imaging device. When activated, the auxiliary equipment that aremodular devices can automatically pair with the surgical hub 106, 206that is located within a particular vicinity of the modular devices aspart of their initialization process. The surgical hub 106, 206 can thenderive contextual information about the surgical procedure by detectingthe types of modular devices that pair with it during this pre-operativeor initialization phase. In this particular example, the surgical hub106, 206 determines that the surgical procedure is a VATS procedurebased on this particular combination of paired modular devices. Based onthe combination of the data from the patient's EMR, the list of medicalsupplies to be used in the procedure, and the type of modular devicesthat connect to the hub, the surgical hub 106, 206 can generally inferthe specific procedure that the surgical team will be performing. Oncethe surgical hub 106, 206 knows what specific procedure is beingperformed, the surgical hub 106, 206 can then retrieve the steps of thatprocedure from a memory or from the cloud and then cross-reference thedata it subsequently receives from the connected data sources (e.g.,modular devices and patient monitoring devices) to infer what step ofthe surgical procedure the surgical team is performing.

Fifth step 5210, the staff members attach the EKG electrodes and otherpatient monitoring devices to the patient. The EKG electrodes and otherpatient monitoring devices are able to pair with the surgical hub 106,206. As the surgical hub 106, 206 begins receiving data from the patientmonitoring devices, the surgical hub 106, 206 thus confirms that thepatient is in the operating theater.

Sixth step 5212, the medical personnel induce anesthesia in the patient.The surgical hub 106, 206 can infer that the patient is under anesthesiabased on data from the modular devices and/or patient monitoringdevices, including EKG data, blood pressure data, ventilator data, orcombinations thereof, for example. Upon completion of the sixth step5212, the pre-operative portion of the lung segmentectomy procedure iscompleted and the operative portion begins.

Seventh step 5214, the patient's lung that is being operated on iscollapsed (while ventilation is switched to the contralateral lung). Thesurgical hub 106, 206 can infer from the ventilator data that thepatient's lung has been collapsed, for example. The surgical hub 106,206 can infer that the operative portion of the procedure has commencedas it can compare the detection of the patient's lung collapsing to theexpected steps of the procedure (which can be accessed or retrievedpreviously) and thereby determine that collapsing the lung is the firstoperative step in this particular procedure.

Eighth step 5216, the medical imaging device (e.g., a scope) is insertedand video from the medical imaging device is initiated. The surgical hub106, 206 receives the medical imaging device data (i.e., video or imagedata) through its connection to the medical imaging device. Upon receiptof the medical imaging device data, the surgical hub 106, 206 candetermine that the laparoscopic portion of the surgical procedure hascommenced. Further, the surgical hub 106, 206 can determine that theparticular procedure being performed is a segmentectomy, as opposed to alobectomy (note that a wedge procedure has already been discounted bythe surgical hub 106, 206 based on data received at the second step 5204of the procedure). The data from the medical imaging device 124 (FIG. 2)can be utilized to determine contextual information regarding the typeof procedure being performed in a number of different ways, including bydetermining the angle at which the medical imaging device is orientedwith respect to the visualization of the patient's anatomy, monitoringthe number or medical imaging devices being utilized (i.e., that areactivated and paired with the surgical hub 106, 206), and monitoring thetypes of visualization devices utilized. For example, one technique forperforming a VATS lobectomy places the camera in the lower anteriorcorner of the patient's chest cavity above the diaphragm, whereas onetechnique for performing a VATS segmentectomy places the camera in ananterior intercostal position relative to the segmental fissure. Usingpattern recognition or machine learning techniques, for example, thesituational awareness system can be trained to recognize the positioningof the medical imaging device according to the visualization of thepatient's anatomy. As another example, one technique for performing aVATS lobectomy utilizes a single medical imaging device, whereas anothertechnique for performing a VATS segmentectomy utilizes multiple cameras.As yet another example, one technique for performing a VATSsegmentectomy utilizes an infrared light source (which can becommunicably coupled to the surgical hub as part of the visualizationsystem) to visualize the segmental fissure, which is not utilized in aVATS lobectomy. By tracking any or all of this data from the medicalimaging device, the surgical hub 106, 206 can thereby determine thespecific type of surgical procedure being performed and/or the techniquebeing used for a particular type of surgical procedure.

Ninth step 5218, the surgical team begins the dissection step of theprocedure. The surgical hub 106, 206 can infer that the surgeon is inthe process of dissecting to mobilize the patient's lung because itreceives data from the RF or ultrasonic generator indicating that anenergy instrument is being fired. The surgical hub 106, 206 cancross-reference the received data with the retrieved steps of thesurgical procedure to determine that an energy instrument being fired atthis point in the process (i.e., after the completion of the previouslydiscussed steps of the procedure) corresponds to the dissection step. Incertain instances, the energy instrument can be an energy tool mountedto a robotic arm of a robotic surgical system.

Tenth step 5220, the surgical team proceeds to the ligation step of theprocedure. The surgical hub 106, 206 can infer that the surgeon isligating arteries and veins because it receives data from the surgicalstapling and cutting instrument indicating that the instrument is beingfired. Similarly to the prior step, the surgical hub 106, 206 can derivethis inference by cross-referencing the receipt of data from thesurgical stapling and cutting instrument with the retrieved steps in theprocess. In certain instances, the surgical instrument can be a surgicaltool mounted to a robotic arm of a robotic surgical system.

Eleventh step 5222, the segmentectomy portion of the procedure isperformed. The surgical hub 106, 206 can infer that the surgeon istransecting the parenchyma based on data from the surgical stapling andcutting instrument, including data from its cartridge. The cartridgedata can correspond to the size or type of staple being fired by theinstrument, for example. As different types of staples are utilized fordifferent types of tissues, the cartridge data can thus indicate thetype of tissue being stapled and/or transected. In this case, the typeof staple being fired is utilized for parenchyma (or other similartissue types), which allows the surgical hub 106, 206 to infer that thesegmentectomy portion of the procedure is being performed.

Twelfth step 5224, the node dissection step is then performed. Thesurgical hub 106, 206 can infer that the surgical team is dissecting thenode and performing a leak test based on data received from thegenerator indicating that an RF or ultrasonic instrument is being fired.For this particular procedure, an RF or ultrasonic instrument beingutilized after parenchyma was transected corresponds to the nodedissection step, which allows the surgical hub 106, 206 to make thisinference. It should be noted that surgeons regularly switch back andforth between surgical stapling/cutting instruments and surgical energy(i.e., RF or ultrasonic) instruments depending upon the particular stepin the procedure because different instruments are better adapted forparticular tasks. Therefore, the particular sequence in which thestapling/cutting instruments and surgical energy instruments are usedcan indicate what step of the procedure the surgeon is performing.Moreover, in certain instances, robotic tools can be utilized for one ormore steps in a surgical procedure and/or handheld surgical instrumentscan be utilized for one or more steps in the surgical procedure. Thesurgeon(s) can alternate between robotic tools and handheld surgicalinstruments and/or can use the devices concurrently, for example. Uponcompletion of the twelfth step 5224, the incisions are closed up and thepost-operative portion of the procedure begins.

Thirteenth step 5226, the patient's anesthesia is reversed. The surgicalhub 106, 206 can infer that the patient is emerging from the anesthesiabased on the ventilator data (i.e., the patient's breathing rate beginsincreasing), for example.

Lastly, the fourteenth step 5228 is that the medical personnel removethe various patient monitoring devices from the patient. The surgicalhub 106, 206 can thus infer that the patient is being transferred to arecovery room when the hub loses EKG, BP, and other data from thepatient monitoring devices. As can be seen from the description of thisillustrative procedure, the surgical hub 106, 206 can determine or inferwhen each step of a given surgical procedure is taking place accordingto data received from the various data sources that are communicablycoupled to the surgical hub 106, 206.

Situational awareness is further described in U.S. Provisional PatentApplication Ser. No. 62/659,900, titled METHOD OF HUB COMMUNICATION,filed Apr. 19, 2018, which is herein incorporated by reference in itsentirety. In certain instances, operation of a robotic surgical system,including the various robotic surgical systems disclosed herein, forexample, can be controlled by the hub 106, 206 based on its situationalawareness and/or feedback from the components thereof and/or based oninformation from the cloud 104.

Situational awareness can play an important role in how a surgical hub(e.g. 106, 206, 5104) responds or reacts to various sensed parameters.For brevity, the following discussion is focused on the surgical hub5104. It is, however, understood, that the following discussion is alsoapplicable to other surgical hubs described herein such as, for example,the surgical hubs 106, 206.

In one aspect, the adjustment of a surgical hub 5104 response to asensed parameter or event can be based on a second pre-existing sensedstep, situation, or parameter. In one aspect, the surgical hub 5104 canhave a first response to a trigger in a first situation and a secondresponse to the same trigger under a second situation.

FIG. 16 is a logic flow diagram of a process 206500 depicting a controlprogram or a logic configuration for adjusting surgical hub responses.The process 206500 can be performed by any suitable control circuit suchas, for example, a control circuit of a surgical hub (e.g. surgical hub106, 206). The process 206500 includes receiving 206502 data from atleast one data source communicably coupled to the surgical hub 5104. Theat least one data source can be, for example, a patient monitoringdevice, a surgical staff detection device, a module device detectiondevice and/or hospital database is processed by the surgical hub 106,206 to determine a progress status of a surgical procedure. The receiveddata can be determinative of a situational parameter of a surgicalprocedure that is being performed by the surgical hub. In variousexamples, the situational parameter represents a progress status of thesurgical procedure, as illustrated in FIG. 17.

FIG. 17 is a timeline 206501 of an illustrative surgical procedure andthe corresponding information inferred by a surgical hub 5104 during theprocedure, in accordance with at least one aspect of the presentdisclosure. The timeline 206501 is similar in many respects to thetimeline 5200 of FIG. 15. In addition, the timeline 206500 furtherdepicts a progress status of the surgical procedure. The progress statusmay comprise a preoperative status 206503 that reflects that thesurgical procedure is underway. In the preoperative status, variouspreoperative steps are performed to prepare the operating room forsurgery. The progress status may also comprise an intraoperative status206505 that reflects that the surgery has begun.

In various examples, activation of a surgical hub in an operating roomsignifies that a surgical procedure has started and, is underway, whichcauses the surgical hub to detect a preoperative status 206503.Additional data sources could also be relied upon, alone or incombination, in detecting the preoperative status 206503. For example,receiving 5206 a scan of a patient band via a scanner that iscommunicably connected to the surgical hub 5104 can indicate apreoperative status 206503. Additionally, or alternatively, receiving5210 data from a patient monitoring device such as, for example, an EKGcan indicate a preoperative status 206503.

As described above, the surgical hub 5104 can infer that the patient isunder anesthesia based on data from the modular devices and/or patientmonitoring devices, including EKG data, blood pressure data, ventilatordata, or combinations thereof, for example. Upon completion of the sixthstep 5212, the pre-operative portion of the lung segmentectomy procedureis completed. Accordingly, receiving such data can indicate a transitionfrom the preoperative status 206503 to the intraoperative status 206505.

In one aspect, the surgical hub controls can be based on the awarenessof whether or not a procedure is in process (i.e., whether a surgicalprocedure is currently being performed in connection with the particularsurgical hub). Accordingly, the surgical hub controls can be based onthe situation in which it senses itself.

The process 206500 further includes adjusting 206504 a response to asensed parameter based on the determined situational parameter orprogress status of the surgical procedure. In at least one example, asillustrated in FIG. 21, the sensed parameter can be detecting securitythreat. In other examples, the sensed parameter can be detecting asurgeon. In other examples, the sensed parameter can be detecting aninstrument fault such as, for example, a modular device.

FIG. 18 illustrates is a logic flow diagram of a process 206520depicting a control program or a logic configuration for selectingoperational modes of a surgical hub 5104, in a surgical procedure,depending on a determined progress status of the surgical procedure. Theprocess 2065520 can be performed by any suitable control circuit suchas, for example, a control circuit of a surgical hub 5104. Data can bereceived 206522 from at least one data source, and may include patientdata 206532 from a patient monitoring device, surgical staff data 206534from a surgical staff detection device, modular device data 206536 fromone or more modular devices and/or hospital data 206538 from a hospitaldatabase, as illustrated in FIG. 19. The received 206522 data isprocessed by the surgical hub 5104 to determine a progress status of thesurgical procedure.

As illustrated in FIG. 18, the received 206522 data can be utilized bythe surgical hub 5104 to determine 206523 whether the surgical procedureis underway. If not, the surgical hub 5104 activates or selects aprevious procedure/network interaction mode 206524. If, however, thesurgical hub 5104 determines 206523 that the surgical procedure isunderway, it further determines 206525 whether surgery is in progress.If not, the surgical hub 5104 activates or selects aninteractive/configurable control mode 206526. If, however, the surgicalhub 5104 determines 206525 that the surgery is in progress, the surgicalhub 5104 activates or selects an instrument display control & proceduraldisplay mode 206528

The mode 206524 is more restrictive than the mode 206526, and the mode206526 is more restrictive than the mode 206528. This arrangement isdesigned to take into consideration a user error in the form ofinadvertent commands, for example. Before the surgical procedure starts,the mode 206524 only permits access to previous procedure data, and alimited interaction with a cloud-based system 104, 204, for example.During the preoperative steps, but before surgery is begun, the mode206526 provides a less restrictive interface that permits a user toaccess and/or configure various parameters and/or controls without beingable to use or activate such controls. In the least restrictive mode206528, which is only available during surgery, the user is allowed touse or activate controls of certain modular devices depending on thesurgical step being performed, as illustrated in FIG. 23.

A surgical hub can make inferences about events that are occurringduring the course of a surgical procedure and then respond accordingly.FIG. 19 addresses determining 206523 whether a surgical procedure isunderway, in accordance with the process 206520, for example. A surgicalhub can sense (or determine or infer) whether or not it is in aprocedure based on attached devices and data feeds to, e.g., selectivelyshow real-time data or the previous surgery's data.

As described above, data from various data sources can be analyzed, forexample by a surgical hub 5104, to determine 206523 whether a surgicalprocedure is underway. Patient data 206532 from one or more patientmonitoring devices can be used to determine 206531 whether a patient ispresent in the operating room. Additionally, or alternatively, surgicalstaff data 206534 from a surgical staff detection device can be used todetermine 206533 whether the necessary supporting staff for the surgicalprocedure is present in the operating room. Additionally, oralternatively, modular device data 206536 from one or more modulardevices can be used to determine 206535 whether the equipment necessaryfor performing the surgical procedure is present in the operating room.Additionally, or alternatively, hospital data 206538 from one or morehospital databases can be used to determine 206537 the type of procedurebeing performed, for example.

The determinations at 206531, 206533, 206535, 206537 can be usedseparately, or in any suitable combination, to determine 206523 whethera surgical procedure is underway. In various examples, each of thedeterminations at 206531, 206533, 206535, 206537 can be assigned apredetermined value when achieved. The summation of all the values canthen be compared to a predetermined threshold to determine 206523whether the surgical procedure is underway. In certain examples, asurgical hub 5104 must achieve each of the determinations at 206531,206533, 206535, 206537 before determining 206523 that a surgicalprocedure is underway.

Referring still to FIG. 19, the patient data 206532 may include patientblood pressure data from a blood pressure monitoring device, heart ratedata from a heart rate monitoring device, anesthesia data, and/orventilator data from a ventilator and/or data from a patientidentification tag. Other data sources from other devices that interactwith the patient within the operating room are also contemplated by thepresent disclosure. For example, as described above in greater detail, asurgical hub 5104 can receive a unique identifier from, for example, ascanner for scanning the patient's wristband encoding the uniqueidentifier associated with the patient when the patient enters theoperating theater.

Furthermore, surgical staff data 206534 from a surgical staff detectiondevice can be analyzed to determine the identity of the individuals inthe operating room and/or where they are located with respect to thepatient. For example, surgical staff data 206534 can be analyzed toassess whether a surgeon is standing in close proximity to the patient.For example, a surgical hub can receive a unique identifier from, forexample, a scanner for scanning surgical staff wristbands encoding theunique identifier associated with each member of the surgical staffpatient when they enters the operating theater. Other techniques foridentifying a patient and/or a surgical staff are disclosed in U.S.Provisional Application No. 62/659,900, titled METHOD OF HUBCOMMUNICATION, filed on Apr. 19, 2018, which is hereby incorporated byreference herein in its entirety.

Further to the above, the modular device data 206536 may includeidentification data for determining what devices are present in theoperating room and/or what devices are active and/or paired with asurgical hub, for example. In one exemplification, a surgical hub can beconfigured to compare the list of items for a procedure (scanned by thescanner, for example) and/or a list of devices paired with the surgicalhub to a recommended or anticipated manifest of items and/or devices forthe given surgical procedure to determine 206535 whether the necessaryequipment for the surgical are present in the operating room.

Further to the above, the hospital data 206538 may include EMR data thatcan be pulled from an EMR database containing patient records. Based onselect patient data in the EMR, a surgical hub can determine the type ofprocedure to be performed, for example, which is helpful in assessingwhether the surgical procedure is underway. In various examples, it iscontemplated that other 206539 data can be received and analyzed by asurgical hub to determine 206523 whether a surgical procedure isunderway, in accordance with the process 206520, for example.

FIG. 20 addresses determining 206525 whether surgery is in progress, inaccordance with the process 206520, for example. Additional patient data206542 such as, for example, active blood pressure data and/or sedationdata can be analyzed by a surgical hub 5104 to determine 206525 whethersurgery is in progress and/or assess the current surgical step beingperformed, as discussed below in connection with FIG. 23 Additionally,or alternatively, various device data 206544 such as, for example,generator data, device activation data, and/or live imaging data (withinstrument identification and/or active moving images) can be analyzedby a surgical hub 5104 to determine 206525 whether surgery is inprogress. In various examples, it is contemplated that other 206546 datacan be received and analyzed by a surgical hub to determine 206525whether surgery is in progress, in accordance with the process 206520,for example.

As described above, the process 206500 includes adjusting 206504 aresponse to a sensed parameter based on a determined situationalparameter or progress status of a surgical procedure. In at least oneexample, as illustrated in FIG. 21, the sensed parameter can bedetecting 206552 a security threat. In other examples, the sensedparameter can be detecting 206554 a surgeon. In other examples, thesensed parameter can be detecting 20559 an instrument fault such as, forexample, a modular device.

Further to the above, responding to a detected 206552 security threatdepends on whether surgery is progress, which can be determined 206525,as described above in connection with FIG. 20. If it is determined206525 that surgery is in progress, an isolated operation mode 206553can be activated. If surgery is not in progress, the current securitylevel can escalated 206551 to a higher security level, and anappropriate reaction or response can be taken to address the detected206552 security threat.

In various examples, the isolated operation mode 206553 comprisesinterrupting communications with external systems such as, for example,the cloud-based system 104, 204. In certain examples, the communicationsinterruption excludes local communications within an operating room suchas, for example, instrument-to-instrument communications,instrument-to-surgical hub 106, 206 communications, and/or remotecontroller-to-instrument communications.

Referring still to FIG. 21, responding to a detected 206554 surgeondepends on whether the surgical procedure is underway, which can bedetermined 206523, as described above in connection with FIG. 20. If itis determined 206523 that a surgical procedure is underway, linkedinstruments can be set 206557 to pre-defined parameters based onprevious use configurations for the detected 206554 surgeon, forexample. If, however, a surgical procedure is not underway, previouscaptured data and/or previous surgeries data can be called up 206555,for example.

Referring still to FIG. 21, responding to a detected 206556 instrumentfault depends on whether the surgical procedure is underway, and furtherdepends on whether surgery is in progress which can be determined206523, 206525, as described above in connection with FIG. 20. Aninstrument can be, for example, a modular device. If it is determined206523 that a surgical procedure is underway, and it is furtherdetermined 206525 that surgery is in progress, a limp mode can beactivated 206565 for the instrument. If, however, a surgical procedureis not underway, a lockout of the surgical instrument can be engaged206561 to prevent the surgical instrument from being used. Furthermore,if it is determined 206523 that a surgical procedure is underway, butsurgery is not in progress, an alert or warning can be issued 206563 bythe surgical hub 5104 to the surgical staff, for example, advisingoptions.

Referring to FIG. 22, an example is provided for adjusting operationalparameters of a surgical stapler 206570 in the event of a detected206572 security fault in accordance with one or more of theabove-described processes. In the example of FIG. 22, the stapler 206570detected 206572 the security fault during communication with a surgicalhub 5104 and/or with a cloud-based system 104, 204, for example. Inresponse, the stapler 206570 severs 206573 communications with thesurgical hub 5104 and/or with the cloud-based system 104, 204, andcontinues to allow autonomous operation unless a hack is detected.

FIG. 23 is a diagram depicting how a surgical hub 5104 can determinewhich step of a surgery is being performed according to various datafeeds, in accordance with at least one aspect of the present disclosure.FIG. 23 also depicts various examples of responding to sensed parametersbased on a determined situational parameter, in accordance with theprocess 206500 (FIG. 16). In the examples of FIG. 23, the determinedsituational parameter is the present step of an ongoing surgery.

In various instances, a surgical hub 5104 determines the present step ofan ongoing surgery based on data received 206502 (FIG. 16) from variousdata sources described in connection with FIG. 16. In the example ofFIG. 23, the surgical hub 5104 identifies the surgical steps of thesurgery as Access 206580, Dissection 206582, Transection 206584,Anastomosis 206586, and Closing 206588, which is based on the received206502 data. Furthermore, the surgical hub 5104 identifies the modulardevices to be used in the surgery as a Trocar 206581, a modular energydevice 206583, a linear surgical stapler 206585, and a circular surgicalstapler 206585, also based on the received 206502 data.

In various examples, the surgical hub 5104 may store a database ofvarious surgeries, the identity and order of the surgical stepspertaining to each of the surgeries, and/or the identity and/or usage oractivation frequency of the modular surgical devices to be used in eachof the surgical steps. In such examples, a user input selecting oridentifying the surgery to be performed may be all that is needed forthe surgical hub 5104 to identify the surgical steps and modularsurgical devices associated with the surgery to be performed.

In other examples, the surgical hub 5104 deduces the type of surgery tobe performed, and/or its corresponding surgical steps, by detectingmodular surgical devices that are in close proximity to the patientand/or are within the operating room. Additionally, or alternatively,the surgical hub 5104 may determine the type of surgery to be performed,and/or its corresponding surgical steps, from a received 206502 patientEMR, for example.

FIG. 23 depicts example information that is made available to and/or isdeduced by the surgical hub 5104 in connection with an example surgery206591 that is being coordinated by the surgical hub 5104, which isbased on the received 206502 data. In access 206580, the trocar 206581and the modular energy device 206583 are used. Usage of the modularenergy device 206583 is depicted in activation instances 206590, whichcan be repeated with or without interruptions, as depicted in FIG. 23.Each activation instance 206590 may comprise a predefined time period ofenergy application by the modular energy device 206583, for example.Similar activation instances 206592, 206594, 206596 are depicted for thetrocar 206581, the linear surgical stapler 206585, and the circularsurgical stapler 206585, respectively.

FIG. 23 also depicts erroneous, inadvertent, or unexpected activationinstances 206590′, 206596′, which constitute examples of sensedparameters, in accordance with the process 206500 (FIG. 16). The exampleactivation instances 206590′, 206596′ are activation instances of themodular energy device 206583 and the circular surgical stapler 206585,respectively, which are outside the expected, or normal, sequence of thesurgery 206591 and, as such, are ignored. Alternatively, oradditionally, an activation instance can be ignored if it is determinedthat the activated modular device is too far away from the surgicalsite. For example, an activation instance can be ignored if it isdetermined that the activated modular device is located on a steriletable, for example. Any suitable proximity sensors can be employed todetermine the position of the activated modular device. Alternatively,or additionally, an activation instance can be ignored if it isdetermined that the activated modular device is not in contact withtissue. Any suitable continuity sensors can be employed to determinewhether the activated modular device is in contact with tissue.

In various examples, the surgical hub 5104 could ignore hand pieceactivation based on depression of the buttons on the handle of a modularenergy device if the surgical hub 5104 is aware the generator, surgicalhub 5104, and/or the modular energy device are not in an active surgery.This can reduce inadvertent activation of devices. Furthermore, thiscould operate on a finer control level as well: If the surgical hub 5104determines that the modular energy device is not inside the patient orin contact with a patient's tissue by sensing continuity or the linkingof the return path of the return pad, the activation of the modularenergy device could be ignored. This could even be used relative topatient proximity in aspects where the system is capable of instrumenttracking.

In one aspect, the surgical hub controls can be programmed such thatfault detection during a surgery triggers a different response thanfault detection does before or after a surgery. Accordingly, theseverity of the surgical hub's response to faults can be based on itsawareness of its use status.

FIG. 24 is a logic flow diagram of a process 206600 depicting a controlprogram or a logic configuration for determining 206602 whether amodular device is in optimal condition and/or performing 206604 aseverity assessment in the event it is determined that the modulardevice is in a suboptimal condition or is not functioning properly. Asurgical hub 5104 may receive 206601 data from various sourcesindicative of device usage history, device status, recent performance,device authentication/identification data, device compatibility, and/orother data. The surgical hub 5104 may analyze such data to determine206602 whether a modular device is in optimal condition. If so, thesurgical hub 5104 permits the modular device to operate in a fullyenabled device mode 206603. If not, the surgical hub 5104 performs206604 a severity assessment. Based on the severity assessment, thesurgical hub 5104 may take steps to provide a warning 206605, cause areduction in available device functionality 206606, force a devicechange 206607, and/or take any other suitable action 206608.

In one aspect, a detected fault severity response can be based onwhether the surgical hub 5104 believes the device is unsafe or could beput into a limp mode because it is currently in-use. For example, if acounterfeit cartridge reload is used in a procedure, the user is warned206605, but the product is allowed to be used with surgeon override ifthe modular device is already in-use. As opposed to a reload beinginstalled at the beginning of a procedure, for example in thepre-operative stage, at which point the severity it senses might be ahigher level and it may lock-out the use of that combination ofproducts. As another example, the number of uses flag can be treated inone manner before and after the procedure, as opposed to it beingtriggered during a procedure. The surgical hub's inclination to lockouta device that has been reused too many times before a procedure can beoverridden to allow the device to continue if the trigger is activatedwhile in a procedure. The inclination to lockout the device can then berestored once the procedure is complete.

In one aspect, security responses in certain situations could besubstantially more restrictive based on the situational awareness of thesurgical hub 5104. Accordingly, surgical hub's security response can bebased on its perceived need for secure use. For example, the protectivereaction to a system attack might be elevated if the system is awarethat it is in-use. As another example, the protective response to anattack might be escalated if surgical hubs are already aware they areunder attack in other locations. As yet another example, remote accessfor controlling aspects of the modules within the surgical hub 5104could be limited when the surgical hub is in use in a procedure. In oneimplementation, the external control aspects of the modular devicescould be disabled when local control is established. In anotherimplementation, when remote access is requested and a procedure is inprocess or there is a sensed use by a local user, the surgical hub mightrequest confirmation locally for permission before granting permissionfor remote control of the system or function.

In one aspect, the configuration and responses of the surgical hub 5104could be altered based on the user the surgical hub senses is in-use.Accordingly, the surgical hubs can be programmed to automaticallyre-configure based on sensed users. For example, the defaultconfiguration of an attached device and the controls of the device couldbe adjusted based on the user the surgical hub senses is using thedevice. If a specific surgeon doing a specific procedure always tends touse a device or its control in a repeatable manner, the surgical hubcould automatically configure the device for the user as its learns hisor her behavior. As another example, the surgical hub 5104 can learn thebehaviors of the users it works with. This could even be with a networkof hubs, which could each communicate preferences, setups, andalterations in device setup for specific users. Accordingly, when aspecific user is sensed, either by login or another technique, thesurgical hub 5104 could then start configuring the systems based onprevious uses by the user in question.

In various aspects, a modular device 5102 such as, for example, asurgical instrument may interact with other modular devices 5102 and/orsurgical hubs 5104. The interaction may occur before, during, and/orafter a surgical procedure commences. For example, the modular device5102 may receive a firmware update from a surgical hub 5104 before thesurgical procedure. In another example, the modular device 5102 mayreceive commands from a remote controller during a surgical procedure.In yet another example, the modular device 5102 may transmit usage datato a surgical hub 5104 regarding a surgical procedure after completionof the surgical procedure. Unauthorized interactions between a modulardevice 5102 and other modular devices 5102 and/or surgical hubs 5104 caninterfere with the proper operation of such devices and systems.

Ensuring a secure interaction between a modular device 5102 and othermodular devices 5102 and/or surgical hubs 5104 can be achieved bygenerating an appropriate response to an unauthorized interaction. Invarious aspects, the response of a modular device 5102 to a potentialsecurity violation or unauthorized interaction can be adjusted based onsituational awareness. In some situations, the response of a modulardevice 5102 to a potential security violation or unauthorizedinteraction can be based on situational awareness that the modulardevice 5102 itself is attacked, instead of a surgical hub 5104, forexample.

In one aspect, a wirelessly pairable modular device 5102 can beprogrammed for detection and escalation of security responses inresponse to numerous or increasing severity threats. For example, thefirst response to a first violation results in a minor reaction and asecond response to a second serial violation results in an escalatedresponse. In another aspect, the escalated response could be terminationof communication and/or autonomous usage only of the instrument.

In one aspect, a surgical instrument can be programmed to implement anescalation protocol to react according to the number or invasiveness ofa security violation. Accordingly, a surgical instrument can beprogrammed to escalate security response in response to increasingthreats. For example, a wireless device which pairs to another device orsurgical hub and senses a first unauthorized or unauthentic interactioncauses the device to execute a minor response (e.g., warn the user orraise the threat warning). When the device senses multiple additionalissues or the severity of the additional issue is higher, the device'ssecond response can be escalated much greater than the first response(e.g., end communication and only operate autonomously or only acceptfully authenticated and encrypted requests). As another example, adevice can execute a security response when communication interactionappears probing after already flagging an unauthentic handshake.

FIG. 25 is a logic flow diagram of a process 206610 depicting a controlprogram or a logic configuration for generating suitable responses tounauthorized interactions with a modular device 5102, in accordance withat least one aspect of the present disclosure. The process 206610includes detecting 206612 a first security violation or unauthorizedinteraction, causing 206614 the modular device 5102 to generate a firstresponse to the first security violation or unauthorized interaction,storing 206616 a record of the first security violation or unauthorizedinteraction; detecting 206618 a second security violation orunauthorized interaction, and causing 206620 the modular device 5102 togenerate a second response to the second security violation orunauthorized interaction, wherein the second response is escalated fromthe first response.

Referring to FIG. 26, in various examples, a modular device 5102comprises a communication module 206622, a control circuit 206624, and auser interface 206626. The control circuit 206624 is coupled to thecommunication module 206622 and the user interface 206626, and isconfigured to execute the process of 206610.

In various examples, any suitable wireless communication can be employedby the communication module 206622 including, for example, Bluetoothwireless technology standard for exchanging data over short distances(using short-wavelength UHF radio waves in the ISM band from 2.4 to2.485 GHz) from fixed and mobile devices and building personal areanetworks (PANs). The communication module 206622 may employ anyone of anumber of wireless or wired communication standards or protocols,including but not limited to Wi-Fi (IEEE 802.11 family), WiMAX (IEEE802.16 family), IEEE 802.20, long-term evolution (LTE), and Ev-DO,HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, and Ethernetderivatives thereof, as well as any other wireless and wired protocolsthat are designated as 3G, 4G, 5G, and beyond. In at least one example,the communication module 206622 may employ an Air Titan-Bluetooth.

In at least one example, a pairing attempt with the communication module205522 by an unauthorized modular device or surgical hub is detected206612. In response, the control circuit 206624 may cause 206614 theuser interface 206624 to issue a warning or an alert, which can a visualand/or an audible alert. Furthermore, the modular device 5102 may store206616 a record of the first pairing attempt in a memory unit of thecontrol circuit 206624, for example.

If, however, a second pairing attempt by an unauthorized modular deviceor surgical hub is detected 206618, the control circuit 206624 may cause206620 a second response, escalated from the first response, to begenerated. For example, the control circuit 206624 may cause thecommunication module 206622 to terminate all external communicationsand/or may cause an autonomous operation mode to be activated.

In at least one example, the modular device 5102 is a surgical stapler,and the first security violation or unauthorized interaction involvesloading a spent, or previously used, staple cartridge onto the surgicalstapler. Detecting 206612 the spent staple cartridge can be achieved byone or more sensors and/or by interrogating a chip of the staplecartridge to assess whether its identification number is associated witha new or unspent staple cartridge. Once a first spent staple cartridgeis detected 206612, the control circuit 206624 causes 206614 the userinterface 206626 to issue to issue a warning or an alert, which can avisual and/or an audible alert. The alert may include instructions toremove the spent staple cartridge.

Further to the above, the modular device 5102 may store 206616 a recordof the spent staple cartridge in a memory unit of the control circuit206624, for example. If, however, the control circuit 206624 detects206618 that the same spent staple cartridge, or another spent staplecartridge, has been loaded onto the surgical stapler, a more escalatedresponse can be generated by the control circuit 206624. For example,the control circuit 206624 may cause the surgical stapler to enter apermanent lockout, preventing the surgical stapler from further usage.The control circuit 206624 may also report the incident to a surgicalhub, for example. Other suitable escalated responses are contemplated bythe present disclosure.

FIG. 27 is a logic flow diagram of a process 206630 depicting a controlprogram or a logic configuration for generating suitable responses tounauthorized interactions with a modular device 5102, in accordance withat least one aspect of the present disclosure. A first unauthorizedactivation of the modular device 5102 is detected 206632 by the controlcircuit 206624, for example. In at least one example, an activation ofthe modular device 5102 while the device is on a surgical tray, or whilethe device is separated from the patient beyond a predetermineddistance, is considered an unauthorized activation. The control circuit206624 causes the modular device 5102 to generate 206634 a firstresponse to a first unauthorized activation, which can be a minorresponse (e.g., warn the user or raise the threat warning). In oneexample, the control circuit 206624 may cause the user interface 206626to issue a warning or an alert, which can a visual and/or an audiblealert. Furthermore, the modular device 5102 may store 206636 a record ofthe first unauthorized activation in a memory unit of the controlcircuit 206624, for example. Furthermore, a second unauthorizedactivation of the modular device 5102 is detected 206638, the controlcircuit 206624 cause the modular device 5102 to generate a secondresponse to the second unauthorized activation of the modular device5102, wherein the second response is escalated from the first response.

In various aspects, a surgical hub can be configured to provide surgicalhub 5104 feedback to a user. The feedback could be adjusted based on aconnotation resulting from a different connotation. In one aspect, asurgical hub 5104 can be programmed to provide interactive feedback tothe user that enables adjustment of a device or display based onpresence of an actionable aspect of the task at hand for the user. Inone aspect, the interactive feedback could include visualizationimprovements identified by the surgical hub/visualization module thatcould provide better or more complete imaging of the surgical site. Inone aspect, the interactive feedback could include an alternate imagingoverlay demonstrating how a device could be better articulated when adevice is placed in an inopportune location.

In one aspect, the surgical hub or displays could be affected based onthe sensing of an action context for the user. Accordingly, displayadjustments could be based on the surgical hub's awareness of actionablecontext.

Various aspects of the subject matter described herein are set out inthe following numbered examples:

Example 1

A surgical instrument for use with a surgical hub in a surgicalprocedure, wherein the surgical instrument comprises a surgical endeffector, a communication module configured to wirelessly pair thesurgical instrument to the surgical hub, and a control circuit. Thecontrol circuit is configured to detect a first security violation,cause the surgical instrument to generate a first response to the firstsecurity violation, store a record of the first security violation,detect a second security violation, and cause the surgical instrument togenerate a second response to the second security violation, wherein thesecond response is escalated from the first response.

Example 2

The surgical instrument of Example 1, wherein the second securityviolation is greater in severity than the first security violation.

Example 3

The surgical instrument of Examples 1 or 2, wherein the first responsecomprises issuance of a warning.

Example 4

The surgical instrument of any one of Examples 1-3, wherein the secondresponse comprises deactivating the communication module.

Example 5

The surgical instrument of any one of Examples 1-4, wherein the secondresponse comprises activating an autonomous usage mode of the surgicalinstrument.

Example 6

A surgical instrument for use with a surgical hub in a surgicalprocedure, wherein the surgical instrument comprises a surgical endeffector, a communication module configured to wirelessly pair thesurgical instrument to the surgical hub, and a control circuit. Thecontrol circuit is configured to detect a first unauthorizedinteraction, cause the surgical instrument to generate a first responseto the first unauthorized interaction, store a record of the firstunauthorized interaction, detect a second unauthorized interaction, andcause the surgical instrument to generate a second response to thesecond unauthorized interaction, wherein the second response isescalated from the first response.

Example 7

The surgical instrument of Example 6, wherein the second unauthorizedinteraction is greater in severity than the first unauthorizedinteraction.

Example 8

The surgical instrument of Examples 6 or 7, wherein the first responsecomprises issuance of a warning.

Example 9

The surgical instrument of any one of Examples 6-8, wherein the secondresponse comprises deactivating the communication module.

Example 10

The surgical instrument of any one of Examples 6-9, wherein the secondresponse comprises activating an autonomous usage mode of the surgicalinstrument.

Example 11

A surgical instrument for use with a surgical hub in a surgicalprocedure, wherein the surgical instrument comprises a surgical endeffector, a communication module configured to wirelessly pair thesurgical instrument to the surgical hub, and a control circuit. Thecontrol circuit is configured to detect a first unauthorized activationof the surgical instrument, cause the surgical instrument to generate afirst response to the first unauthorized activation of the surgicalinstrument, store a record of the first unauthorized activation of thesurgical instrument, detect a second unauthorized activation of thesurgical instrument, and cause the surgical instrument to generate asecond response to the second unauthorized activation of the surgicalinstrument, wherein the second response is escalated from the firstresponse.

Example 12

The surgical instrument of Example 11, wherein the second unauthorizedinteraction is greater in severity than the first unauthorizedinteraction.

Example 13

The surgical instrument of Examples 11 or 12, wherein the first responsecomprises issuance of a warning.

Example 14

The surgical instrument of any one of Examples 11-13, wherein the secondresponse comprises deactivating the communication module.

Example 15

The surgical instrument of any one of Examples 11-14, wherein the secondresponse comprises activating an autonomous usage mode of the surgicalinstrument.

While several forms have been illustrated and described, it is not theintention of Applicant to restrict or limit the scope of the appendedclaims to such detail. Numerous modifications, variations, changes,substitutions, combinations, and equivalents to those forms may beimplemented and will occur to those skilled in the art without departingfrom the scope of the present disclosure. Moreover, the structure ofeach element associated with the described forms can be alternativelydescribed as a means for providing the function performed by theelement. Also, where materials are disclosed for certain components,other materials may be used. It is therefore to be understood that theforegoing description and the appended claims are intended to cover allsuch modifications, combinations, and variations as falling within thescope of the disclosed forms. The appended claims are intended to coverall such modifications, variations, changes, substitutions,modifications, and equivalents.

The foregoing detailed description has set forth various forms of thedevices and/or processes via the use of block diagrams, flowcharts,and/or examples. Insofar as such block diagrams, flowcharts, and/orexamples contain one or more functions and/or operations, it will beunderstood by those within the art that each function and/or operationwithin such block diagrams, flowcharts, and/or examples can beimplemented, individually and/or collectively, by a wide range ofhardware, software, firmware, or virtually any combination thereof.Those skilled in the art will recognize that some aspects of the formsdisclosed herein, in whole or in part, can be equivalently implementedin integrated circuits, as one or more computer programs running on oneor more computers (e.g., as one or more programs running on one or morecomputer systems), as one or more programs running on one or moreprocessors (e.g., as one or more programs running on one or moremicroprocessors), as firmware, or as virtually any combination thereof,and that designing the circuitry and/or writing the code for thesoftware and or firmware would be well within the skill of one of skillin the art in light of this disclosure. In addition, those skilled inthe art will appreciate that the mechanisms of the subject matterdescribed herein are capable of being distributed as one or more programproducts in a variety of forms, and that an illustrative form of thesubject matter described herein applies regardless of the particulartype of signal bearing medium used to actually carry out thedistribution.

Instructions used to program logic to perform various disclosed aspectscan be stored within a memory in the system, such as dynamic randomaccess memory (DRAM), cache, flash memory, or other storage.Furthermore, the instructions can be distributed via a network or by wayof other computer readable media. Thus a machine-readable medium mayinclude any mechanism for storing or transmitting information in a formreadable by a machine (e.g., a computer), but is not limited to, floppydiskettes, optical disks, compact disc, read-only memory (CD-ROMs), andmagneto-optical disks, read-only memory (ROMs), random access memory(RAM), erasable programmable read-only memory (EPROM), electricallyerasable programmable read-only memory (EEPROM), magnetic or opticalcards, flash memory, or a tangible, machine-readable storage used in thetransmission of information over the Internet via electrical, optical,acoustical or other forms of propagated signals (e.g., carrier waves,infrared signals, digital signals, etc.). Accordingly, thenon-transitory computer-readable medium includes any type of tangiblemachine-readable medium suitable for storing or transmitting electronicinstructions or information in a form readable by a machine (e.g., acomputer).

As used in any aspect herein, the term “control circuit” may refer to,for example, hardwired circuitry, programmable circuitry (e.g., acomputer processor including one or more individual instructionprocessing cores, processing unit, processor, microcontroller,microcontroller unit, controller, digital signal processor (DSP),programmable logic device (PLD), programmable logic array (PLA), orfield programmable gate array (FPGA)), state machine circuitry, firmwarethat stores instructions executed by programmable circuitry, and anycombination thereof. The control circuit may, collectively orindividually, be embodied as circuitry that forms part of a largersystem, for example, an integrated circuit (IC), an application-specificintegrated circuit (ASIC), a system on-chip (SoC), desktop computers,laptop computers, tablet computers, servers, smart phones, etc.Accordingly, as used herein “control circuit” includes, but is notlimited to, electrical circuitry having at least one discrete electricalcircuit, electrical circuitry having at least one integrated circuit,electrical circuitry having at least one application specific integratedcircuit, electrical circuitry forming a general purpose computing deviceconfigured by a computer program (e.g., a general purpose computerconfigured by a computer program which at least partially carries outprocesses and/or devices described herein, or a microprocessorconfigured by a computer program which at least partially carries outprocesses and/or devices described herein), electrical circuitry forminga memory device (e.g., forms of random access memory), and/or electricalcircuitry forming a communications device (e.g., a modem, communicationsswitch, or optical-electrical equipment). Those having skill in the artwill recognize that the subject matter described herein may beimplemented in an analog or digital fashion or some combination thereof.

As used in any aspect herein, the term “logic” may refer to an app,software, firmware and/or circuitry configured to perform any of theaforementioned operations. Software may be embodied as a softwarepackage, code, instructions, instruction sets and/or data recorded onnon-transitory computer readable storage medium. Firmware may beembodied as code, instructions or instruction sets and/or data that arehard-coded (e.g., nonvolatile) in memory devices.

As used in any aspect herein, the terms “component,” “system,” “module”and the like can refer to a computer-related entity, either hardware, acombination of hardware and software, software, or software inexecution.

As used in any aspect herein, an “algorithm” refers to a self-consistentsequence of steps leading to a desired result, where a “step” refers toa manipulation of physical quantities and/or logic states which may,though need not necessarily, take the form of electrical or magneticsignals capable of being stored, transferred, combined, compared, andotherwise manipulated. It is common usage to refer to these signals asbits, values, elements, symbols, characters, terms, numbers, or thelike. These and similar terms may be associated with the appropriatephysical quantities and are merely convenient labels applied to thesequantities and/or states.

A network may include a packet switched network. The communicationdevices may be capable of communicating with each other using a selectedpacket switched network communications protocol. One examplecommunications protocol may include an Ethernet communications protocolwhich may be capable permitting communication using a TransmissionControl Protocol/Internet Protocol (TCP/IP). The Ethernet protocol maycomply or be compatible with the Ethernet standard published by theInstitute of Electrical and Electronics Engineers (IEEE) titled “IEEE802.3 Standard”, published in December, 2008 and/or later versions ofthis standard. Alternatively or additionally, the communication devicesmay be capable of communicating with each other using an X.25communications protocol. The X.25 communications protocol may comply orbe compatible with a standard promulgated by the InternationalTelecommunication Union-Telecommunication Standardization Sector(ITU-T). Alternatively or additionally, the communication devices may becapable of communicating with each other using a frame relaycommunications protocol. The frame relay communications protocol maycomply or be compatible with a standard promulgated by ConsultativeCommittee for International Telegraph and Telephone (CCITT) and/or theAmerican National Standards Institute (ANSI). Alternatively oradditionally, the transceivers may be capable of communicating with eachother using an Asynchronous Transfer Mode (ATM) communications protocol.The ATM communications protocol may comply or be compatible with an ATMstandard published by the ATM Forum titled “ATM-MPLS NetworkInterworking 2.0” published August 2001, and/or later versions of thisstandard. Of course, different and/or after-developedconnection-oriented network communication protocols are equallycontemplated herein.

Unless specifically stated otherwise as apparent from the foregoingdisclosure, it is appreciated that, throughout the foregoing disclosure,discussions using terms such as “processing,” “computing,”“calculating,” “determining,” “displaying,” or the like, refer to theaction and processes of a computer system, or similar electroniccomputing device, that manipulates and transforms data represented asphysical (electronic) quantities within the computer system's registersand memories into other data similarly represented as physicalquantities within the computer system memories or registers or othersuch information storage, transmission or display devices.

One or more components may be referred to herein as “configured to,”“configurable to,” “operable/operative to,” “adapted/adaptable,” “ableto,” “conformable/conformed to,” etc. Those skilled in the art willrecognize that “configured to” can generally encompass active-statecomponents and/or inactive-state components and/or standby-statecomponents, unless context requires otherwise.

The terms “proximal” and “distal” are used herein with reference to aclinician manipulating the handle portion of the surgical instrument.The term “proximal” refers to the portion closest to the clinician andthe term “distal” refers to the portion located away from the clinician.It will be further appreciated that, for convenience and clarity,spatial terms such as “vertical”, “horizontal”, “up”, and “down” may beused herein with respect to the drawings. However, surgical instrumentsare used in many orientations and positions, and these terms are notintended to be limiting and/or absolute.

Those skilled in the art will recognize that, in general, terms usedherein, and especially in the appended claims (e.g., bodies of theappended claims) are generally intended as “open” terms (e.g., the term“including” should be interpreted as “including but not limited to,” theterm “having” should be interpreted as “having at least,” the term“includes” should be interpreted as “includes but is not limited to,”etc.). It will be further understood by those within the art that if aspecific number of an introduced claim recitation is intended, such anintent will be explicitly recited in the claim, and in the absence ofsuch recitation no such intent is present. For example, as an aid tounderstanding, the following appended claims may contain usage of theintroductory phrases “at least one” and “one or more” to introduce claimrecitations. However, the use of such phrases should not be construed toimply that the introduction of a claim recitation by the indefinitearticles “a” or “an” limits any particular claim containing suchintroduced claim recitation to claims containing only one suchrecitation, even when the same claim includes the introductory phrases“one or more” or “at least one” and indefinite articles such as “a” or“an” (e.g., “a” and/or “an” should typically be interpreted to mean “atleast one” or “one or more”); the same holds true for the use ofdefinite articles used to introduce claim recitations.

In addition, even if a specific number of an introduced claim recitationis explicitly recited, those skilled in the art will recognize that suchrecitation should typically be interpreted to mean at least the recitednumber (e.g., the bare recitation of “two recitations,” without othermodifiers, typically means at least two recitations, or two or morerecitations). Furthermore, in those instances where a conventionanalogous to “at least one of A, B, and C, etc.” is used, in generalsuch a construction is intended in the sense one having skill in the artwould understand the convention (e.g., “a system having at least one ofA, B, and C” would include but not be limited to systems that have Aalone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). In those instances where aconvention analogous to “at least one of A, B, or C, etc.” is used, ingeneral such a construction is intended in the sense one having skill inthe art would understand the convention (e.g., “a system having at leastone of A, B, or C” would include but not be limited to systems that haveA alone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). It will be furtherunderstood by those within the art that typically a disjunctive wordand/or phrase presenting two or more alternative terms, whether in thedescription, claims, or drawings, should be understood to contemplatethe possibilities of including one of the terms, either of the terms, orboth terms unless context dictates otherwise. For example, the phrase “Aor B” will be typically understood to include the possibilities of “A”or “B” or “A and B.”

With respect to the appended claims, those skilled in the art willappreciate that recited operations therein may generally be performed inany order. Also, although various operational flow diagrams arepresented in a sequence(s), it should be understood that the variousoperations may be performed in other orders than those which areillustrated, or may be performed concurrently. Examples of suchalternate orderings may include overlapping, interleaved, interrupted,reordered, incremental, preparatory, supplemental, simultaneous,reverse, or other variant orderings, unless context dictates otherwise.Furthermore, terms like “responsive to,” “related to,” or otherpast-tense adjectives are generally not intended to exclude suchvariants, unless context dictates otherwise.

It is worthy to note that any reference to “one aspect,” “an aspect,”“an exemplification,” “one exemplification,” and the like means that aparticular feature, structure, or characteristic described in connectionwith the aspect is included in at least one aspect. Thus, appearances ofthe phrases “in one aspect,” “in an aspect,” “in an exemplification,”and “in one exemplification” in various places throughout thespecification are not necessarily all referring to the same aspect.Furthermore, the particular features, structures or characteristics maybe combined in any suitable manner in one or more aspects.

Any patent application, patent, non-patent publication, or otherdisclosure material referred to in this specification and/or listed inany Application Data Sheet is incorporated by reference herein, to theextent that the incorporated materials is not inconsistent herewith. Assuch, and to the extent necessary, the disclosure as explicitly setforth herein supersedes any conflicting material incorporated herein byreference. Any material, or portion thereof, that is said to beincorporated by reference herein, but which conflicts with existingdefinitions, statements, or other disclosure material set forth hereinwill only be incorporated to the extent that no conflict arises betweenthat incorporated material and the existing disclosure material.

In summary, numerous benefits have been described which result fromemploying the concepts described herein. The foregoing description ofthe one or more forms has been presented for purposes of illustrationand description. It is not intended to be exhaustive or limiting to theprecise form disclosed. Modifications or variations are possible inlight of the above teachings. The one or more forms were chosen anddescribed in order to illustrate principles and practical application tothereby enable one of ordinary skill in the art to utilize the variousforms and with various modifications as are suited to the particular usecontemplated. It is intended that the claims submitted herewith definethe overall scope.

What is claimed is:
 1. A surgical instrument for use with a surgical hubin a surgical procedure, wherein the surgical instrument comprises: asurgical end effector; a communication module configured to wirelesslypair the surgical instrument to the surgical hub; and a control circuitconfigured to: detect a first security violation; cause the surgicalinstrument to generate a first response to the first security violation;store a record of the first security violation; detect a second securityviolation; and cause the surgical instrument to generate a secondresponse to the second security violation, wherein the second responseis escalated from the first response.
 2. The surgical instrument ofclaim 1, wherein the second security violation is greater in severitythan the first security violation.
 3. The surgical instrument of claim1, wherein the first response comprises issuance of a warning.
 4. Thesurgical instrument of claim 1, wherein the second response comprisesdeactivating the communication module.
 5. The surgical instrument ofclaim 1, wherein the second response comprises activating an autonomoususage mode of the surgical instrument.
 6. A surgical instrument for usewith a surgical hub in a surgical procedure, wherein the surgicalinstrument comprises: a surgical end effector; a communication moduleconfigured to wirelessly pair the surgical instrument to the surgicalhub; and a control circuit configured to: detect a first unauthorizedinteraction; cause the surgical instrument to generate a first responseto the first unauthorized interaction; store a record of the firstunauthorized interaction; detect a second unauthorized interaction; andcause the surgical instrument to generate a second response to thesecond unauthorized interaction, wherein the second response isescalated from the first response.
 7. The surgical instrument of claim6, wherein the second unauthorized interaction is greater in severitythan the first unauthorized interaction.
 8. The surgical instrument ofclaim 6, wherein the first response comprises issuance of a warning. 9.The surgical instrument of claim 6, wherein the second responsecomprises deactivating the communication module.
 10. The surgicalinstrument of claim 6, wherein the second response comprises activatingan autonomous usage mode of the surgical instrument.
 11. A surgicalinstrument for use with a surgical hub in a surgical procedure, whereinthe surgical instrument comprises: a surgical end effector; acommunication module configured to wirelessly pair the surgicalinstrument to the surgical hub; and a control circuit configured to:detect a first unauthorized activation of the surgical instrument; causethe surgical instrument to generate a first response to the firstunauthorized activation of the surgical instrument; store a record ofthe first unauthorized activation of the surgical instrument; detect asecond unauthorized activation of the surgical instrument; and cause thesurgical instrument to generate a second response to the secondunauthorized activation of the surgical instrument, wherein the secondresponse is escalated from the first response.
 12. The surgicalinstrument of claim 11, wherein the second unauthorized interaction isgreater in severity than the first unauthorized interaction.
 13. Thesurgical instrument of claim 11, wherein the first response comprisesissuance of a warning.
 14. The surgical instrument of claim 11, whereinthe second response comprises deactivating the communication module. 15.The surgical instrument of claim 11, wherein the second responsecomprises activating an autonomous usage mode of the surgicalinstrument.